NDC 0703-4154

Idarubicin Hydrochloride

Idarubicin Hydrochloride

Idarubicin Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Idarubicin Hydrochloride.

Product ID0703-4154_50496107-74f2-4f7f-9654-0462d555e282
NDC0703-4154
Product TypeHuman Prescription Drug
Proprietary NameIdarubicin Hydrochloride
Generic NameIdarubicin Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2002-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA065036
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameIDARUBICIN HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0703-4154-11

1 VIAL, SINGLE-DOSE in 1 CARTON (0703-4154-11) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2002-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-4154-11 [00703415411]

Idarubicin Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065036
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-10-01

NDC 0703-4154-91 [00703415491]

Idarubicin Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065036
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-10-01
Marketing End Date2012-12-31

Drug Details

Active Ingredients

IngredientStrength
IDARUBICIN HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:d521b65f-3fd2-4efe-8cab-b444921dd223
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1791500
  • 1791493
  • 1791498
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Idarubicin Hydrochloride" or generic name "Idarubicin Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9217Idarubicin HydrochlorideIdarubicin Hydrochloride
    0143-9218Idarubicin HydrochlorideIdarubicin Hydrochloride
    0143-9219Idarubicin HydrochlorideIdarubicin Hydrochloride
    0143-9306Idarubicin HydrochlorideIdarubicin Hydrochloride
    0143-9307Idarubicin HydrochlorideIdarubicin Hydrochloride
    0143-9308Idarubicin HydrochlorideIdarubicin Hydrochloride
    0703-4154Idarubicin HydrochlorideIdarubicin Hydrochloride
    0703-4155Idarubicin HydrochlorideIdarubicin Hydrochloride
    0703-4156Idarubicin HydrochlorideIdarubicin Hydrochloride
    63323-194Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDE
    66758-055Idarubicin HydrochlorideIdarubicin Hydrochloride
    0013-2576Idamycin PFSidarubicin hydrochloride
    0013-2586Idamycin PFSidarubicin hydrochloride
    0013-2596Idamycin PFSidarubicin hydrochloride

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