NDC 0143-9307

Idarubicin Hydrochloride

Idarubicin Hydrochloride

Idarubicin Hydrochloride 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 Idarubicin Hydrochloride.

Product ID0143-9307_89ebbab3-6e1c-4647-85e7-e8f9f20566c6
NDC0143-9307
Product TypeHuman Prescription Drug
Proprietary NameIdarubicin Hydrochloride
Generic NameIdarubicin Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-12
Marketing CategoryANDA / ANDA
Application NumberANDA065275
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameIDARUBICIN HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0143-9307-01

1 VIAL, GLASS in 1 BOX (0143-9307-01) > 10 mL in 1 VIAL, GLASS
Marketing Start Date2018-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9307-01 [00143930701]

Idarubicin Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065275
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-12

Drug Details

Active Ingredients

IngredientStrength
IDARUBICIN HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:7c20b574-285b-49eb-a98e-6752e4bb481d
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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