NDC 65219-550

Pralatrexate

Pralatrexate

Pralatrexate is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Pralatrexate.

Product ID65219-550_510bc71b-20e4-428a-8fc2-29c9fc20f2f3
NDC65219-550
Product TypeHuman Prescription Drug
Proprietary NamePralatrexate
Generic NamePralatrexate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-11-15
Marketing CategoryNDA AUTHORIZED GENERIC /
Application NumberNDA022468
Labeler NameFresenius Kabi USA, LLC
Substance NamePRALATREXATE
Active Ingredient Strength20 mg/mL
Pharm ClassesFolate Analog Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65219-550-01

1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-11-15
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Pralatrexate" or generic name "Pralatrexate"

NDCBrand NameGeneric Name
65219-550PralatrexatePralatrexate
65219-552PralatrexatePralatrexate
48818-001Folotynpralatrexate
72893-003Folotynpralatrexate
72893-005Folotynpralatrexate

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