Paclitaxel: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Paclitaxel Injection USP, 30 mg/vial — Vial Label

paclitaxel-30mg-vial-label
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Paclitaxel Injection USP, 30 mg/vial — Carton Label

paclitaxel-30mg-carton-label
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Paclitaxel Injection USP, 100 mg/vial — Vial Label

paclitaxel-100mg-vial-label
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Paclitaxel Injection USP, 100 mg/vial — Carton Label

paclitaxel-100mg-carton-label
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Paclitaxel Injection USP, 300 mg/vial — Vial Label

paclitaxel-300mg-vial-label
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Paclitaxel Injection USP, 300 mg/vial — Carton Label

paclitaxel-300mg-carton-label
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PACLITAXEL paclitaxel injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-620
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
POLYOXYL 35 CASTOR OIL
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-620-05 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (62332-620-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216874 10/20/2022
PACLITAXEL paclitaxel injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-621
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
POLYOXYL 35 CASTOR OIL
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-621-17 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 16.7 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (62332-621-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216874 10/20/2022
PACLITAXEL paclitaxel injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-622
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
POLYOXYL 35 CASTOR OIL
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-622-50 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (62332-622-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216874 10/20/2022
Labeler — Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 675480402 MANUFACTURE (62332-620), MANUFACTURE (62332-621), MANUFACTURE (62332-622)

Revised: 10/2022 Alembic Pharmaceuticals Inc.

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