PEMETREXED - pemetrexed disodium injection, powder, lyophilized, for solution 
Zydus Lifesciences Limited

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Pemetrexed for injection, for Intravenous Use

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

100 mg vial label

NDC 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

100 mg carton label

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

500 mg vial label

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

500 mg carton label

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

1,000 mg vial label

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

1,000 mg carton label
PEMETREXED 
pemetrexed disodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1691
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO) PEMETREXED100 mg  in 4 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A) 106 mg  in 4 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1691-11 in 1 CARTON05/26/2022
14 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21407305/26/2022
PEMETREXED 
pemetrexed disodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1692
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO) PEMETREXED500 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A) 500 mg  in 20 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1692-11 in 1 CARTON05/26/2022
120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21407305/26/2022
PEMETREXED 
pemetrexed disodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1693
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO) PEMETREXED1000 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A) 1000 mg  in 40 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1693-11 in 1 CARTON05/26/2022
140 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21407305/26/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Hospira Oncology Private Limited676190889ANALYSIS(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)

Revised: 5/2022
Document Id: fc5f4aa1-92c4-444b-8e64-53708c9a67bc
Set id: 6986de29-b077-48ac-ad2b-0cc478f72d89
Version: 1
Effective Time: 20220526
 
Zydus Lifesciences Limited