Pemetrexed
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED injection, for intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
8b660f68-b770-4e0a-b2f9-25e663deecc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2022
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pemetrexed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-4515
Application NumberNDA208419
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
PEMETREXED MONOHYDRATEActive
Quantity: 25 mg in 1 mL
Code: 236Y2F7D9J
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
Pemetrexed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-4514
Application NumberNDA208419
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (5)
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEMETREXED MONOHYDRATEActive
Quantity: 25 mg in 1 mL
Code: 236Y2F7D9J
Classification: ACTIB
Pemetrexed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-4516
Application NumberNDA208419
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (5)
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PEMETREXED MONOHYDRATEActive
Quantity: 25 mg in 1 mL
Code: 236Y2F7D9J
Classification: ACTIB