NDC 66758-055

Idarubicin Hydrochloride

Idarubicin Hydrochloride

Idarubicin Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Idarubicin Hydrochloride.

Product ID66758-055_615d206a-b178-4ff4-b6c1-7e349099f3c7
NDC66758-055
Product TypeHuman Prescription Drug
Proprietary NameIdarubicin Hydrochloride
Generic NameIdarubicin Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA091293
Labeler NameSandoz Inc
Substance NameIDARUBICIN HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 66758-055-05

20 mL in 1 VIAL, SINGLE-USE (66758-055-05)
Marketing Start Date2011-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66758-055-05 [66758005505]

Idarubicin Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA091293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-29
Marketing End Date2011-03-29

NDC 66758-055-01 [66758005501]

Idarubicin Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA091293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-29
Marketing End Date2011-03-29

NDC 66758-055-03 [66758005503]

Idarubicin Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA091293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-29
Marketing End Date2011-03-29

Drug Details

Active Ingredients

IngredientStrength
IDARUBICIN HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:615d206a-b178-4ff4-b6c1-7e349099f3c7
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

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