NDC 0143-9549

Adriamycin

Doxorubicin Hydrochloride

Adriamycin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Doxorubicin Hydrochloride.

Product ID0143-9549_75df5244-3f0e-4e0b-9591-bb7c7fac9dbb
NDC0143-9549
Product TypeHuman Prescription Drug
Proprietary NameAdriamycin
Generic NameDoxorubicin Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1996-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA062975
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameDOXORUBICIN HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0143-9549-01

1 VIAL in 1 BOX (0143-9549-01) > 5 mL in 1 VIAL
Marketing Start Date1996-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9549-01 [00143954901]

Adriamycin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062975
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-05-01

NDC 0143-9549-10 [00143954910]

Adriamycin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062975
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-05-01

Drug Details

Active Ingredients

IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:0f153c1e-efce-4276-8273-d9e4c8455d16
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799310
  • 1191138
  • 1799308
  • 1799307
  • 1799305
  • 1790099
  • 1790097
  • 1790100
  • Pharmacological Class

    • Anthracycline Topoisomerase Inhibitor [EPC]
    • Anthracyclines [CS]
    • Topoisomerase Inhibitors [MoA]

    NDC Crossover Matching brand name "Adriamycin" or generic name "Doxorubicin Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9277AdriamycinAdriamycin
    0143-9547AdriamycinAdriamycin
    0143-9275AdriamycinAdriamycin
    0143-9549AdriamycinAdriamycin
    0143-9548AdriamycinAdriamycin
    0143-9546AdriamycinAdriamycin
    0143-9370AdriamycinAdriamycin
    0143-9372AdriamycinAdriamycin
    0143-9369AdriamycinAdriamycin
    0143-9371AdriamycinAdriamycin
    0069-3030Doxorubicin HydrochlorideDoxorubicin Hydrochloride
    0069-3031Doxorubicin HydrochlorideDoxorubicin Hydrochloride
    0069-3032Doxorubicin HydrochlorideDoxorubicin Hydrochloride
    0069-3033Doxorubicin HydrochlorideDoxorubicin Hydrochloride
    0069-3034Doxorubicin HydrochlorideDoxorubicin Hydrochloride
    0069-4004Doxorubicin HydrochlorideDoxorubicin Hydrochloride
    0069-4015Doxorubicin HydrochlorideDoxorubicin Hydrochloride
    0069-4026Doxorubicin HydrochlorideDoxorubicin Hydrochloride

    Trademark Results [Adriamycin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADRIAMYCIN
    ADRIAMYCIN
    90408775 not registered Live/Pending
    Hikma Pharmaceuticals USA Inc.
    2020-12-23
    ADRIAMYCIN
    ADRIAMYCIN
    73363443 1276678 Dead/Cancelled
    Farmitalia Carlo Erba S.p.A.
    1982-05-07

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