NDC 16729-248

Mitomycin

Mitomycin

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

Product ID16729-248_957d71ba-7471-6cb4-e053-2995a90a3dc0
NDC16729-248
Product TypeHuman Prescription Drug
Proprietary NameMitomycin
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-05-03
Marketing CategoryANDA / ANDA
Application NumberANDA064144
Labeler NameAccord Healthcare Inc
Substance NameMITOMYCIN
Active Ingredient Strength40 mg/10mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16729-248-38

1 VIAL in 1 CARTON (16729-248-38) > 10 mL in 1 VIAL
Marketing Start Date2013-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-248-38 [16729024838]

Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA064144
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-05-03

Drug Details

Active Ingredients

IngredientStrength
MITOMYCIN40 mg/10mL

OpenFDA Data

SPL SET ID:3a1300e9-ca6e-4713-b41a-bb913aed3287
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740898
  • 1740900
  • UPC Code
  • 0316729247115
  • 0316729248389
  • Pharmacological Class

    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]

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

    NDCBrand NameGeneric Name
    0143-9135MitomycinMitomycin
    0143-9136MitomycinMitomycin
    0143-9279MitomycinMitomycin
    0143-9280MitomycinMitomycin
    16729-108MitomycinMitomycin
    16729-115MitomycinMitomycin
    16729-116MitomycinMitomycin
    16729-246MitomycinMitomycin
    16729-247MitomycinMitomycin
    16729-248MitomycinMitomycin
    67457-518MitomycinMitomycin
    67457-519MitomycinMitomycin
    67457-520MitomycinMitomycin
    67457-995MitomycinMitomycin
    67457-996MitomycinMitomycin
    67457-997MitomycinMitomycin
    68001-389MitomycinMitomycin
    68001-390MitomycinMitomycin
    68001-391MitomycinMitomycin
    68083-483MITOMYCINMITOMYCIN
    68083-484MITOMYCINMITOMYCIN
    68083-502MITOMYCINMITOMYCIN
    71288-137MITOMYCINMITOMYCIN
    71288-138MITOMYCINMITOMYCIN
    69605-103JELMYTOmitomycin
    49771-002Mitosolmitomycin
    69448-001MUTAMYCINMitomycin
    69448-002MUTAMYCINMitomycin
    69448-003MUTAMYCINMitomycin

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