NDC 0143-9583

Irinotecan Hydrochloride

Irinotecan Hydrochloride

Irinotecan Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Irinotecan Hydrochloride.

Product ID0143-9583_9ca4f1b9-8a5d-459d-9df1-f0f5871ad318
NDC0143-9583
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan Hydrochloride
Generic NameIrinotecan Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA091032
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameIRINOTECAN HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0143-9583-01

5 mL in 1 VIAL, GLASS (0143-9583-01)
Marketing Start Date2010-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9583-01 [00143958301]

Irinotecan Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA091032
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-12-20

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:9c6aa884-750e-4b11-9955-bc7ab6e9c2ad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726324
  • Pharmacological Class

    • Topoisomerase Inhibitor [EPC]
    • Topoisomerase Inhibitors [MoA]
    • Topoisomerase Inhibitor [EPC]
    • Topoisomerase Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    0143-9583Irinotecan HydrochlorideIrinotecan Hydrochloride
    0143-9701Irinotecan HydrochlorideIrinotecan Hydrochloride
    0143-9702Irinotecan HydrochlorideIrinotecan Hydrochloride
    0703-4432Irinotecan HydrochlorideIrinotecan Hydrochloride
    0703-4434Irinotecan HydrochlorideIrinotecan Hydrochloride
    16714-027Irinotecan hydrochlorideIrinotecan hydrochloride
    16714-131Irinotecan hydrochlorideIrinotecan hydrochloride
    16714-725Irinotecan HydrochlorideIrinotecan Hydrochloride
    16714-726Irinotecan HydrochlorideIrinotecan Hydrochloride
    23155-179Irinotecan HydrochlorideIrinotecan Hydrochloride
    25021-230Irinotecan Hydrochlorideirinotecan hydrochloride
    45963-614Irinotecan hydrochlorideIrinotecan hydrochloride
    50742-401Irinotecan HydrochlorideIrinotecan Hydrochloride
    68001-284Irinotecan HydrochlorideIrinotecan Hydrochloride
    50742-402Irinotecan HydrochlorideIrinotecan Hydrochloride
    59923-714Irinotecan HydrochlorideIrinotecan Hydrochloride
    59923-702Irinotecan HydrochlorideIrinotecan Hydrochloride
    60505-6128Irinotecan HydrochlorideIrinotecan Hydrochloride
    59923-715Irinotecan HydrochlorideIrinotecan Hydrochloride
    61703-349Irinotecan HydrochlorideIrinotecan Hydrochloride
    63323-193Irinotecan HydrochlorideIrinotecan Hydrochloride
    67184-0513Irinotecan HydrochlorideIrinotecan Hydrochloride
    67184-0512Irinotecan HydrochlorideIrinotecan Hydrochloride
    67184-0511Irinotecan HydrochlorideIrinotecan Hydrochloride
    68083-382Irinotecan hydrochlorideIrinotecan hydrochloride
    59923-716Irinotecan HydrochlorideIrinotecan Hydrochloride
    0009-1111Camptosaririnotecan hydrochloride
    0009-7529Camptosaririnotecan hydrochloride
    15054-0043OnivydeIRINOTECAN HYDROCHLORIDE

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