ZOLPIDEM TARTRATE: Package Insert and Label Information (Page 4 of 4)

Package/Label Display Panel

Zolpidem Tartrate Tablets, USP CIV

5 mg

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Zolpidem Tartrate Tablets, USP CIV

10 mg

100 Tablets

carton label
(click image for full-size original)
ZOLPIDEM TARTRATE zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6082(NDC:13668-007)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 5 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED
Product Characteristics
Color RED (Red) Score no score
Shape CAPSULE (Capsule) Size 10mm
Flavor Imprint Code 5MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6082-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6082-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 09/05/2007
ZOLPIDEM TARTRATE zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6083(NDC:13668-008)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 10 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (peach-yellow) Score no score
Shape CAPSULE (Capsule) Size 10mm
Flavor Imprint Code 10MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6083-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6083-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 09/05/2007
Labeler — Major Pharmaceuticals (191427277)
Registrant — Major Pharmaceuticals (191427277)

Revised: 10/2019 Major Pharmaceuticals

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