NDC Code(s) : 70121-2453-1, 70121-2461-1, 70121-2462-1
Packager : Amneal Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PEMRYDI RTUPemetrexed disodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-2453
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM HEMIPENTAHYDRATE(UNII: F4GSH45R4C)
(PEMETREXED - UNII:04Q9AIZ7NO) 		PEMETREXED DISODIUM HEMIPENTAHYDRATE100 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70121-2453-11 in 1 CARTON 06/06/2023
110 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
NDA NDA215179 06/06/2023
PEMRYDI RTUPemetrexed disodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-2461
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM HEMIPENTAHYDRATE(UNII: F4GSH45R4C)
(PEMETREXED - UNII:04Q9AIZ7NO) 		PEMETREXED DISODIUM HEMIPENTAHYDRATE500 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70121-2461-11 in 1 CARTON 06/06/2023
150 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
NDA NDA215179 06/06/2023
PEMRYDI RTUPemetrexed disodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-2462
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM HEMIPENTAHYDRATE(UNII: F4GSH45R4C)
(PEMETREXED - UNII:04Q9AIZ7NO) 		PEMETREXED DISODIUM HEMIPENTAHYDRATE1000 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70121-2462-11 in 1 CARTON 06/06/2023
1100 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
NDA NDA215179 06/06/2023

LABELER - Amneal Pharmaceuticals LLC(827748190)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 650348852 analysis(70121-2453, 70121-2461, 70121-2462), manufacture(70121-2453, 70121-2461, 70121-2462)

PRINCIPAL DISPLAY PANEL

NDC  70121-2453-1                                      

PEMRYDI RTU (pemetrexed injection)

100 mg/10 mL (10 mg/mL)

For Intravenous infusion only

Rx only

Amneal Pharmaceuticals LLC

1

1

NDC  70121-2461-1                                      

PEMRYDI RTU (pemetrexed injection)

500 mg/50 mL (10 mg/mL)

For Intravenous infusion only

Rx only

Amneal Pharmaceuticals LLC

11

NDC  70121-2462-1                                      

PEMRYDI RTU (pemetrexed injection)

1,000 mg/100 mL (10 mg/mL)

For Intravenous infusion only

Rx only

Amneal Pharmaceuticals LLC

1

1