NDC 0409-0801

Nipent

Pentostatin

Nipent is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Pentostatin.

Product ID0409-0801_8fa82560-cea4-4272-9ae0-c97ac1635c8b
NDC0409-0801
Product TypeHuman Prescription Drug
Proprietary NameNipent
Generic NamePentostatin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-08-15
Marketing CategoryNDA / NDA
Application NumberNDA020122
Labeler NameHospira, Inc.
Substance NamePENTOSTATIN
Active Ingredient Strength2 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0409-0801-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2007-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-0801-09 [00409080109]

Nipent INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA020122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-15
Marketing End Date2016-10-01

NDC 0409-0801-01 [00409080101]

Nipent INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA020122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-15

Drug Details

Active Ingredients

IngredientStrength
PENTOSTATIN2 mg/mL

OpenFDA Data

SPL SET ID:674e0e6d-46ed-4868-9196-04019d667716
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240573
  • 105607
  • Pharmacological Class

    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]

    NDC Crossover Matching brand name "Nipent" or generic name "Pentostatin"

    NDCBrand NameGeneric Name
    0409-0801NipentPENTOSTATIN
    67457-288PentostatinPentostatin

    Trademark Results [Nipent]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NIPENT
    NIPENT
    74172705 1730233 Live/Registered
    HOSPIRA, INC.
    1991-06-03

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