NDC 72485-212

Irinotecan Hydrochloride 100 mg/5 mL

Irinotecan Hydrochloride

Irinotecan Hydrochloride 100 mg/5 mL is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Armas Pharmacueticals Inc. The primary component is Irinotecan Hydrochloride.

Product ID72485-212_40113c9e-517a-4b59-a888-61224fd26706
NDC72485-212
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan Hydrochloride 100 mg/5 mL
Generic NameIrinotecan Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA208718
Labeler NameArmas Pharmacueticals Inc
Substance NameIRINOTECAN HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72485-212-05

1 VIAL in 1 CARTON (72485-212-05) > 5 mL in 1 VIAL
Marketing Start Date2019-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-212-05 [72485021205]

Irinotecan Hydrochloride 100 mg/5 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:2f160344-4ec6-4285-b293-86c0dd40d8b5
Manufacturer
UNII
UPC Code
  • 0372485212057

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Irinotecan Hydrochloride 100 mg/5 mL" or generic name "Irinotecan Hydrochloride"

    NDCBrand NameGeneric Name
    72485-212Irinotecan Hydrochloride 100 mg/5 mLIrinotecan Hydrochloride 100 mg/5 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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