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Pemetrexed

These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004

Approved
Approval ID

495c6751-8d6f-4093-8108-9bed283fce03

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 5, 2023

Manufacturers
FDA

BluePoint Laboratories

DUNS: 985523874

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 Code68001-537
Application NumberANDA214632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 5, 2023
FDA Product Classification

INGREDIENTS (4)

MANNITOLInactive
Quantity: 1000 mg in 40 mL
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 1000 mg in 40 mL
Code: F4GSH45R4C
Classification: ACTIM

Pemetrexed

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68001-535
Application NumberANDA214632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 5, 2023
FDA Product Classification

INGREDIENTS (4)

MANNITOLInactive
Quantity: 106 mg in 4 mL
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 100 mg in 4 mL
Code: F4GSH45R4C
Classification: ACTIM

Pemetrexed

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68001-536
Application NumberANDA214632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 5, 2023
FDA Product Classification

INGREDIENTS (4)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Quantity: 500 mg in 20 mL
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 500 mg in 20 mL
Code: F4GSH45R4C
Classification: ACTIM

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