NDC 72485-211

Irinotecan Hydrochloride 40 mg/2 mL

Irinotecan Hydrochloride

Irinotecan Hydrochloride 40 mg/2 mL is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is Irinotecan Hydrochloride.

Product ID72485-211_2c48b1cc-14b4-4de2-9cea-58a89cf32147
NDC72485-211
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan Hydrochloride 40 mg/2 mL
Generic NameIrinotecan Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA208718
Labeler NameArmas Pharmaceuticals 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 72485-211-02

1 VIAL in 1 CARTON (72485-211-02) > 2 mL in 1 VIAL
Marketing Start Date2019-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-211-02 [72485021102]

Irinotecan Hydrochloride 40 mg/2 mL INJECTION
Marketing CategoryANDA
Application NumberANDA208718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-01

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:828932fc-8923-4874-9131-980d5d2a2c86
Manufacturer
UNII
UPC Code
  • 0372485211029

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Irinotecan Hydrochloride 40 mg/2 mL" or generic name "Irinotecan Hydrochloride"

    NDCBrand NameGeneric Name
    72485-211Irinotecan Hydrochloride 40 mg/2 mLIrinotecan Hydrochloride 40 mg/2 mL
    68001-425Irinotecan Hydrochloride 40 mg/2 mLIrinotecan Hydrochloride 40 mg/2 mL
    0009-1111Camptosaririnotecan hydrochloride
    0009-7529Camptosaririnotecan hydrochloride
    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
    15054-0043OnivydeIRINOTECAN HYDROCHLORIDE
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