NDC 48818-001

Folotyn

Pralatrexate

Folotyn is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Allos Therapeutics. The primary component is Pralatrexate.

Product ID48818-001_1ed02005-69ec-499f-bf23-3100b06651f8
NDC48818-001
Product TypeHuman Prescription Drug
Proprietary NameFolotyn
Generic NamePralatrexate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-09-24
Marketing CategoryNDA / NDA
Application NumberNDA022468
Labeler NameAllos Therapeutics
Substance NamePRALATREXATE
Active Ingredient Strength20 mg/mL
Pharm ClassesFolate Analog Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 48818-001-01

1 VIAL, SINGLE-USE in 1 CARTON (48818-001-01) > 1 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2009-09-24
Marketing End Date2023-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48818-001-01 [48818000101]

Folotyn INJECTION
Marketing CategoryNDA
Application NumberNDA022468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-24

NDC 48818-001-02 [48818000102]

Folotyn INJECTION
Marketing CategoryNDA
Application NumberNDA022468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-24

Drug Details

Active Ingredients

IngredientStrength
PRALATREXATE20 mg/mL

OpenFDA Data

SPL SET ID:5e4cf15b-bf7b-4b83-863e-e9ef27741a51
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1796419
  • 1796421
  • 1796424
  • 1796425
  • Pharmacological Class

    • Folate Analog Metabolic Inhibitor [EPC]
    • Folate Analog Metabolic Inhibitor [EPC]

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

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

    Trademark Results [Folotyn]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FOLOTYN
    FOLOTYN
    78881722 3743409 Live/Registered
    Allos Therapeutics, Inc.
    2006-05-11
    FOLOTYN
    FOLOTYN
    77939090 3887969 Dead/Cancelled
    Allos Therapeutics, Inc.
    2010-02-18

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