pemetrexed
Pemetrexed for injection, for Intravenous Use
Approved
Approval ID
6986de29-b077-48ac-ad2b-0cc478f72d89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pemetrexed disodium
PRODUCT DETAILS
NDC Product Code70771-1691
Application NumberANDA214073
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2022
Generic Namepemetrexed disodium
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PEMETREXED DISODIUMActive
Quantity: 100 mg in 4 mL
Code: 2PKU919BA9
Classification: ACTIM
MANNITOLInactive
Quantity: 106 mg in 4 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
pemetrexed disodium
PRODUCT DETAILS
NDC Product Code70771-1693
Application NumberANDA214073
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2022
Generic Namepemetrexed disodium
INGREDIENTS (4)
PEMETREXED DISODIUMActive
Quantity: 1000 mg in 40 mL
Code: 2PKU919BA9
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Quantity: 1000 mg in 40 mL
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
pemetrexed disodium
PRODUCT DETAILS
NDC Product Code70771-1692
Application NumberANDA214073
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2022
Generic Namepemetrexed disodium
INGREDIENTS (4)
PEMETREXED DISODIUMActive
Quantity: 500 mg in 20 mL
Code: 2PKU919BA9
Classification: ACTIM
MANNITOLInactive
Quantity: 500 mg in 20 mL
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT