DOCETAXEL (Page 20 of 20)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — Carton 160 mg/8 mL

NDC 16729- 267 -65

Docetaxel Injection 160 mg/8 mL

Rx Only

160 mg/8 mL

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- Carton 160 mg/8 mL
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — Carton 80 mg/4 mL

NDC 16729- 267 -64

Docetaxel Injection 80 mg/4 mL

Rx Only

80 mg/4 mL

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- Carton 80 mg/4 mL
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — Carton 20 mg/mL

NDC 16729- 267 -63

Docetaxel Injection 20 mg/mL

Rx Only

20 mg/mL

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- Carton 20 mg/mL
(click image for full-size original)
DOCETAXEL docetaxel injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-231
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID 4 mg in 1 mL
POLYSORBATE 80 520 mg in 1 mL
ALCOHOL 395 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-231-65 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 8 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (16729-231-65)
2 NDC:16729-231-64 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (16729-231-64)
3 NDC:16729-231-63 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
3 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (16729-231-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201195 07/01/2012 06/21/2019
DOCETAXEL docetaxel injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-267
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID 4 mg in 1 mL
POLYSORBATE 80 520 mg in 1 mL
ALCOHOL 395 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-267-63 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 1 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (16729-267-63)
2 NDC:16729-267-64 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
2 4 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (16729-267-64)
3 NDC:16729-267-65 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
3 8 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (16729-267-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201195 05/30/2013
Labeler — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 manufacture (16729-267), analysis (16729-267)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 915837971 manufacture (16729-267), analysis (16729-267)

Revised: 07/2020 Accord Healthcare Inc.

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