NDC 69448-002

MUTAMYCIN

Mitomycin

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

Product ID69448-002_55ab68d0-c46a-2f41-e054-00144ff88e88
NDC69448-002
Product TypeHuman Prescription Drug
Proprietary NameMUTAMYCIN
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-07-25
Marketing CategoryANDA / ANDA
Application NumberANDA064144
Labeler NameAccord BioPharma Inc.
Substance NameMITOMYCIN
Active Ingredient Strength20 mg/40mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69448-002-11

1 VIAL in 1 BOX, UNIT-DOSE (69448-002-11) > 40 mL in 1 VIAL
Marketing Start Date2017-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69448-002-11 [69448000211]

MUTAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA064144
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-25

Drug Details

Active Ingredients

IngredientStrength
MITOMYCIN20 mg/40mL

OpenFDA Data

SPL SET ID:cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1740898
  • 1740894
  • 1812484
  • 1812480
  • 1740900
  • 1812482
  • UPC Code
  • 0369448002114
  • 0369448001056
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69448-001MUTAMYCINMitomycin
    69448-002MUTAMYCINMitomycin
    69448-003MUTAMYCINMitomycin
    69605-103JELMYTOmitomycin
    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
    49771-002Mitosolmitomycin

    Trademark Results [MUTAMYCIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MUTAMYCIN
    MUTAMYCIN
    86790540 5375762 Live/Registered
    Accord Healthcare, Inc.
    2015-10-16
    MUTAMYCIN
    MUTAMYCIN
    73031486 1023069 Dead/Cancelled
    BRISTOL-MYERS COMPANY
    1974-09-09

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