NDC 67457-519

Mitomycin

Mitomycin

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

Product ID67457-519_cecc31d9-bc8e-4d6f-b46c-4e3b3bea6307
NDC67457-519
Product TypeHuman Prescription Drug
Proprietary NameMitomycin
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA202670
Labeler NameMylan Institutional LLC
Substance NameMITOMYCIN
Active Ingredient Strength20 mg/40mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-519-20

1 VIAL in 1 CARTON (67457-519-20) > 40 mL in 1 VIAL
Marketing Start Date2018-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-519-20 [67457051920]

Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202670
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-28

Drug Details

Active Ingredients

IngredientStrength
MITOMYCIN20 mg/40mL

OpenFDA Data

SPL SET ID:880f1e05-3ac1-436d-b261-9b059291b471
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740894
  • 1740898
  • 1740900
  • UPC Code
  • 0367457520407
  • 0367457519203
  • 0367457518053
  • Pharmacological Class

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