PEMETREXED- pemetrexed disodium injection, powder, lyophilized, for solution

pemetrexed by

Drug Labeling and Warnings

pemetrexed by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited, Zydus Hospira Oncology Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC: 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

NDC: 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC: 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

NDC: 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC: 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

INGREDIENTS AND APPEARANCE

PEMETREXED 
pemetrexed disodium injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1691
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO)	PEMETREXED	100 mg  in 4 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)	106 mg  in 4 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1691-1	1 in 1 CARTON	05/26/2022
1		4 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214073	05/26/2022

PEMETREXED 
pemetrexed disodium injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1692
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO)	PEMETREXED	500 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)	500 mg  in 20 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1692-1	1 in 1 CARTON	05/26/2022
1		20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214073	05/26/2022

PEMETREXED 
pemetrexed disodium injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1693
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO)	PEMETREXED	1000 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)	1000 mg  in 40 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1693-1	1 in 1 CARTON	05/26/2022
1		40 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214073	05/26/2022

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Hospira Oncology Private Limited		676190889	ANALYSIS(70771-1691, 70771-1692, 70771-1693) , LABEL(70771-1691, 70771-1692, 70771-1693) , MANUFACTURE(70771-1691, 70771-1692, 70771-1693) , PACK(70771-1691, 70771-1692, 70771-1693)