NDC 45963-614

Irinotecan hydrochloride

Irinotecan Hydrochloride

Irinotecan hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Irinotecan Hydrochloride.

Product ID45963-614_07bff35e-3999-4898-b96d-cd919c5e99e6
NDC45963-614
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan hydrochloride
Generic NameIrinotecan Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-03-12
Marketing CategoryANDA / ANDA
Application NumberANDA078589
Labeler NameActavis Pharma, 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 45963-614-51

1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2015-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-614-85 [45963061485]

Irinotecan hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078589
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-08-10

NDC 45963-614-51 [45963061451]

Irinotecan hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078589
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-12

NDC 45963-614-55 [45963061455]

Irinotecan hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078589
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-12

NDC 45963-614-81 [45963061481]

Irinotecan hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078589
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-17

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:5e1fdcaa-918f-4cd8-9c7a-4c538d866198
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726319
  • 1726324
    • UPC Code
  • 0345963614513

    • 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
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