NDC 16729-108

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 ID16729-108_0a4ea340-dcd4-2b02-e054-00144ff88e88
NDC16729-108
Product TypeHuman Prescription Drug
Proprietary NameMitomycin
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-06-10
Marketing CategoryANDA / ANDA
Application NumberANDA064144
Labeler NameAccord Healthcare Inc
Substance NameMITOMYCIN
Active Ingredient Strength20 mg/40mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 16729-108-11

1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) > 40 mL in 1 VIAL
Marketing Start Date2009-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-108-11 [16729010811]

Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA064144
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-10

Drug Details

Active Ingredients

IngredientStrength
MITOMYCIN20 mg/40mL

OpenFDA Data

SPL SET ID:ff676355-313d-4575-8f2f-e4a1e9527477
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740894
  • 1740898
  • 1740900
  • UPC Code
  • 0316729115056
  • 0316729116381
  • 0316729108119
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.