NDC 0143-9279

Mitomycin

Mitomycin

Mitomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Mitomycin.

Product ID0143-9279_6bccab87-11af-47b4-bfec-2206939135c1
NDC0143-9279
Product TypeHuman Prescription Drug
Proprietary NameMitomycin
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1996-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA064117
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameMITOMYCIN
Active Ingredient Strength20 mg/40mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0143-9279-01

1 VIAL in 1 BOX, UNIT-DOSE (0143-9279-01) > 40 mL in 1 VIAL
Marketing Start Date1996-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9279-01 [00143927901]

Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA064117
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-05-01

Drug Details

Active Ingredients

IngredientStrength
MITOMYCIN20 mg/40mL

OpenFDA Data

SPL SET ID:5917f7a7-cd20-407b-8dda-9fd58c5f47a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740898
  • 1740900
  • 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.