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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1691
Application NumberANDA214073
Product Classification
M
Marketing Category
C73584
G
Generic Name
pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1693
Application NumberANDA214073
Product Classification
M
Marketing Category
C73584
G
Generic Name
pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1692
Application NumberANDA214073
Product Classification
M
Marketing Category
C73584
G
Generic Name
pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2022
FDA Product Classification
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