NDC 50742-402

Irinotecan Hydrochloride

Irinotecan Hydrochloride

Irinotecan Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Irinotecan Hydrochloride.

Product ID50742-402_096d9fbd-b19c-4ade-a601-1ddad80c0218
NDC50742-402
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan Hydrochloride
Generic NameIrinotecan Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA206935
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameIRINOTECAN HYDROCHLORIDE
Active Ingredient Strength100 mg/5mL
Pharm ClassesTopoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50742-402-05

1 VIAL, GLASS in 1 CARTON (50742-402-05) > 5 mL in 1 VIAL, GLASS
Marketing Start Date2017-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-402-05 [50742040205]

Irinotecan Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA206935
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-05

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE100 mg/5mL

OpenFDA Data

SPL SET ID:d04f2471-3085-4fc8-a657-bb3918d48e6e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726319
  • 1726324
  • UPC Code
  • 0350742401024
  • 0350742402052
  • Pharmacological Class

    • 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

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