NDC 0338-0063

DOXIL

Doxorubicin Hydrochloride

DOXIL is a Intravenous Injection, Suspension, Liposomal in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Doxorubicin Hydrochloride.

Product ID0338-0063_09013f0a-7fd8-4ca2-9bd2-2f0ba9144d8b
NDC0338-0063
Product TypeHuman Prescription Drug
Proprietary NameDOXIL
Generic NameDoxorubicin Hydrochloride
Dosage FormInjection, Suspension, Liposomal
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-08-13
Marketing CategoryNDA / NDA
Application NumberNDA050718
Labeler NameBaxter Healthcare Corporation
Substance NameDOXORUBICIN HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0338-0063-01

1 VIAL, SINGLE-USE in 1 CARTON (0338-0063-01) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2019-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-0063-01 [00338006301]

DOXIL INJECTION, SUSPENSION, LIPOSOMAL
Marketing CategoryNDA
Application NumberNDA050718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-13

Drug Details

Active Ingredients

IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790127
  • 1790131
  • 1790115
  • 1790128

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    59676-960DOXILDOXIL
    0338-0063DOXILDOXIL
    0338-0067DOXILDOXIL
    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 [DOXIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DOXIL
    DOXIL
    74223789 1744235 Live/Registered
    BAXTER HEALTHCARE CORPORATION
    1991-11-21
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