5 GRASS MIX: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL

Allergenic Extract, Alum Precipitated
Center-AL
DIN 0064892230 mL Sterile Multiple Dose Vial

Allergenic Extract, Alum Precipitated Center-AL DIN 00648922 30 mL Sterile Multiple Dose Vial
(click image for full-size original)
5 GRASS MIX phleum pratense pollen, dactylis glomerata pollen, poa pratensis pollen, agrostis gigantea pollen, anthoxanthum odoratum pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8005
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) PHLEUM PRATENSE POLLEN 1000 [PNU] in 1 mL
DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA POLLEN 1000 [PNU] in 1 mL
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 1000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 1000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (ANTHOXANTHUM ODORATUM POLLEN) ANTHOXANTHUM ODORATUM POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8005-05 5.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
5 GRASS MIX phleum pratense pollen, dactylis glomerata pollen, poa pratensis pollen, agrostis gigantea pollen, anthoxanthum odoratum pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8006
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) PHLEUM PRATENSE POLLEN 5000 [PNU] in 1 mL
DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA POLLEN 5000 [PNU] in 1 mL
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 5000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 5000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (ANTHOXANTHUM ODORATUM POLLEN) ANTHOXANTHUM ODORATUM POLLEN 5000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8006-05 5.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
5 GRASS MIX phleum pratense pollen, dactylis glomerata pollen, poa pratensis pollen, agrostis gigantea pollen, anthoxanthum odoratum pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8007
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) PHLEUM PRATENSE POLLEN 10000 [PNU] in 1 mL
DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA POLLEN 10000 [PNU] in 1 mL
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 10000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 10000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (ANTHOXANTHUM ODORATUM POLLEN) ANTHOXANTHUM ODORATUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8007-05 5.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
5 GRASS MIX phleum pratense pollen, dactylis glomerata pollen, poa pratensis pollen, agrostis gigantea pollen, anthoxanthum odoratum pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8010
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) PHLEUM PRATENSE POLLEN 100 [PNU] in 1 mL
DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA POLLEN 100 [PNU] in 1 mL
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 100 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 100 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (ANTHOXANTHUM ODORATUM POLLEN) ANTHOXANTHUM ODORATUM POLLEN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8010-05 5.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
3 GRASS MIX bromus inermis pollen, cynodon dactylon, cynodon dactylon injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8001
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON WHOLE (CYNODON DACTYLON WHOLE) CYNODON DACTYLON WHOLE 20000 [PNU] in 1 mL
BROMUS INERMIS POLLEN (BROMUS INERMIS POLLEN) BROMUS INERMIS POLLEN 20000 [PNU] in 1 mL
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8001-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
4 WEED MIX amaranthus retroflexus pollen, chenopodium album pollen, plantago lanceolata pollen, xanthium strumarium pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8004
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM POLLEN (XANTHIUM STRUMARIUM POLLEN) XANTHIUM STRUMARIUM POLLEN 10000 [PNU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA POLLEN 10000 [PNU] in 1 mL
CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) CHENOPODIUM ALBUM POLLEN 10000 [PNU] in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8004-10 10.5 mL in 1 VIAL None
2 NDC:0268-8004-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
5 GRASS MIX agrostis gigantea pollen, anthoxanthum odoratum, dactylis glomerata, phleum pratense, poa pratensis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8008
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 10000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 10000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 10000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 10000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM (ANTHOXANTHUM ODORATUM) ANTHOXANTHUM ODORATUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8008-10 10.5 mL in 1 VIAL None
2 NDC:0268-8008-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
5 GRASS MIX agrostis gigantea pollen, anthoxanthum odoratum, dactylis glomerata, phleum pratense, poa pratensis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8009
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 20000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 20000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 20000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 20000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM (ANTHOXANTHUM ODORATUM) ANTHOXANTHUM ODORATUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8009-10 10.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
6 GRASS MIX agrostis gigantea pollen, dactylis glomerata, festuca pratensis, lolium perenne, phleum pratense, poa pratensis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8011
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 10000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 10000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 10000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 10000 [PNU] in 1 mL
FESTUCA PRATENSIS (FESTUCA PRATENSIS) FESTUCA PRATENSIS 10000 [PNU] in 1 mL
LOLIUM PERENNE (LOLIUM PERENNE) LOLIUM PERENNE 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8011-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
6 GRASS MIX agrostis gigantea pollen, dactylis glomerata, festuca pratensis, lolium perenne, phleum pratense, poa pratensis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8012
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 20000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 20000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 20000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 20000 [PNU] in 1 mL
FESTUCA PRATENSIS (FESTUCA PRATENSIS) FESTUCA PRATENSIS 20000 [PNU] in 1 mL
LOLIUM PERENNE (LOLIUM PERENNE) LOLIUM PERENNE 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8012-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
7 GRASS MIX agrostis gigantea pollen, anthoxanthum odoratum, dactylis glomerata, festuca pratensis, lolium perenne, phleum pratense, poa pratensis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8013
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 10000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 10000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 10000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 10000 [PNU] in 1 mL
FESTUCA PRATENSIS (FESTUCA PRATENSIS) FESTUCA PRATENSIS 10000 [PNU] in 1 mL
LOLIUM PERENNE (LOLIUM PERENNE) LOLIUM PERENNE 10000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM (ANTHOXANTHUM ODORATUM) ANTHOXANTHUM ODORATUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8013-10 10.5 mL in 1 VIAL None
2 NDC:0268-8013-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
7 GRASS MIX agrostis gigantea pollen, anthoxanthum odoratum, dactylis glomerata, festuca pratensis, lolium perenne, phleum pratense, poa pratensis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8014
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 20000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 20000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 20000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 20000 [PNU] in 1 mL
FESTUCA PRATENSIS (FESTUCA PRATENSIS) FESTUCA PRATENSIS 20000 [PNU] in 1 mL
LOLIUM PERENNE (LOLIUM PERENNE) LOLIUM PERENNE 20000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM (ANTHOXANTHUM ODORATUM) ANTHOXANTHUM ODORATUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8014-10 10.5 mL in 1 VIAL None
2 NDC:0268-8014-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
8 SOUTHERN GRASS MIX agrostis gigantea pollen, cynodon dactylon, dactylis glomerata, festuca pratensis, lolium perenne, phleum pratense, poa pratensis, sorghum halepense pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8015
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON WHOLE (CYNODON DACTYLON WHOLE) CYNODON DACTYLON WHOLE 10000 [PNU] in 1 mL
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 10000 [PNU] in 1 mL
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 10000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 10000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 10000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 10000 [PNU] in 1 mL
FESTUCA PRATENSIS (FESTUCA PRATENSIS) FESTUCA PRATENSIS 10000 [PNU] in 1 mL
LOLIUM PERENNE (LOLIUM PERENNE) LOLIUM PERENNE 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8015-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
8 SOUTHERN GRASS MIX agrostis gigantea pollen, cynodon dactylon, dactylis glomerata, festuca pratensis, lolium perenne, phleum pratense, poa pratensis, sorghum halepense pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8016
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON WHOLE (CYNODON DACTYLON WHOLE) CYNODON DACTYLON WHOLE 20000 [PNU] in 1 mL
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 20000 [PNU] in 1 mL
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 20000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 20000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 20000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 20000 [PNU] in 1 mL
FESTUCA PRATENSIS (FESTUCA PRATENSIS) FESTUCA PRATENSIS 20000 [PNU] in 1 mL
LOLIUM PERENNE (LOLIUM PERENNE) LOLIUM PERENNE 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8016-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
9 SOUTHERN GRASS MIX agrostis gigantea pollen, anthoxanthum odoratum, cynodon dactylon, dactylis glomerata, festuca pratensis, lolium perenne, phleum pratense, poa pratensis, sorghum halepense pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8017
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON WHOLE (CYNODON DACTYLON WHOLE) CYNODON DACTYLON WHOLE 10000 [PNU] in 1 mL
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 10000 [PNU] in 1 mL
PHLEUM PRATENSE (PHLEUM PRATENSE) PHLEUM PRATENSE 10000 [PNU] in 1 mL
DACTYLIS GLOMERATA (DACTYLIS GLOMERATA) DACTYLIS GLOMERATA 10000 [PNU] in 1 mL
POA PRATENSIS (POA PRATENSIS) POA PRATENSIS 10000 [PNU] in 1 mL
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 10000 [PNU] in 1 mL
FESTUCA PRATENSIS (FESTUCA PRATENSIS) FESTUCA PRATENSIS 10000 [PNU] in 1 mL
LOLIUM PERENNE (LOLIUM PERENNE) LOLIUM PERENNE 10000 [PNU] in 1 mL
ANTHOXANTHUM ODORATUM (ANTHOXANTHUM ODORATUM) ANTHOXANTHUM ODORATUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8017-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
9 TREE MIX acer saccharum pollen, alnus rhombifolia pollen, betula lenta pollen, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus alba pollen, quercus alba pollen, ulmus americana pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8023
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 10000 [PNU] in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 10000 [PNU] in 1 mL
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 10000 [PNU] in 1 mL
BETULA LENTA POLLEN (BETULA LENTA POLLEN) BETULA LENTA POLLEN 10000 [PNU] in 1 mL
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 10000 [PNU] in 1 mL
CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 10000 [PNU] in 1 mL
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 10000 [PNU] in 1 mL
POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 10000 [PNU] in 1 mL
PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.005 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8023-30 32 mL in 1 VIAL None
2 NDC:0268-8023-10 10.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
MIXED RAGWEED ambrosia artemisiifolia, ambrosia trifida pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8057
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA (AMBROSIA ARTEMISIIFOLIA) AMBROSIA ARTEMISIIFOLIA 10000 [PNU] in 1 mL
AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8057-10 10.5 mL in 1 VIAL None
2 NDC:0268-8057-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
MIXED RAGWEED ambrosia artemisiifolia, ambrosia trifida pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8058
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA (AMBROSIA ARTEMISIIFOLIA) AMBROSIA ARTEMISIIFOLIA 20000 [PNU] in 1 mL
AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.004 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8058-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975
WESTERN WEED MIX ambrosia acanthicarpa pollen, ambrosia psilostachya pollen, artemisia tridentata pollen, bassia scoparia pollen, salsola kali pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8079
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (BASSIA SCOPARIA POLLEN) BASSIA SCOPARIA POLLEN 10000 [PNU] in 1 mL
ARTEMISIA TRIDENTATA POLLEN (ARTEMISIA TRIDENTATA POLLEN) ARTEMISIA TRIDENTATA POLLEN 10000 [PNU] in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (AMBROSIA PSILOSTACHYA POLLEN) AMBROSIA PSILOSTACHYA POLLEN 10000 [PNU] in 1 mL
AMBROSIA ACANTHICARPA POLLEN (AMBROSIA ACANTHICARPA POLLEN) AMBROSIA ACANTHICARPA POLLEN 10000 [PNU] in 1 mL
SALSOLA KALI POLLEN (SALSOLA KALI POLLEN) SALSOLA KALI POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM ALUMINATE 0.05 g in 1 mL
SODIUM HYDROXIDE 0.01 g in 1 mL
PHENOL 0.004 mL in 1 mL
SODIUM CHLORIDE 0.009 g in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-8079-30 32 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/15/1975 05/24/2023
Labeler — ALK-Abello, Inc. (809998847)

Revised: 05/2023 ALK-Abello, Inc.

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