NDC 0703-4434

Irinotecan Hydrochloride

Irinotecan Hydrochloride

Irinotecan Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines. The primary component is Irinotecan Hydr.

Product ID0703-4434_00ed14d1-24b3-4214-8286-8a2cf579d04c
NDC0703-4434
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan Hydrochloride
Generic NameIrinotecan Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-02-27
Marketing End Date2019-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA090101
Labeler NameTeva Parenteral Medicines
Substance NameIRINOTECAN HYDR
Active Ingredient Strength100 mg/5mL
Pharm ClassesTopoisomerase I
NDC Exclude FlagN

Packaging

NDC 0703-4434-81

1 VIAL, SINGLE-USE in 1 CARTON (0703-4434-81) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2015-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-4434-91 [00703443491]

Irinotecan Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090101
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-24
Marketing End Date2012-03-31

NDC 0703-4434-81 [00703443481]

Irinotecan Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090101
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-01
Marketing End Date2019-06-30

NDC 0703-4434-11 [00703443411]

Irinotecan Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090101
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-02-28
Marketing End Date2019-03-31

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE100 mg/5mL

OpenFDA Data

SPL SET ID:1f9a3c6d-91bd-4862-a27c-ecc1f10426b6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726319
  • 1726324

    • 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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