NDC 0009-7529

Camptosar

Irinotecan Hydrochloride

Camptosar is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Irinotecan Hydrochloride.

Product ID0009-7529_02b55806-a85e-4561-a708-b484ecd81f8f
NDC0009-7529
Product TypeHuman Prescription Drug
Proprietary NameCamptosar
Generic NameIrinotecan Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1996-06-14
Marketing CategoryNDA / NDA
Application NumberNDA020571
Labeler NamePharmacia and Upjohn Company LLC
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 0009-7529-03

1 VIAL, SINGLE-DOSE in 1 CARTON (0009-7529-03) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date1996-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0009-7529-05 [00009752905]

Camptosar INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-06-14

NDC 0009-7529-02 [00009752902]

Camptosar INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-06-14
Marketing End Date2013-06-01

NDC 0009-7529-01 [00009752901]

Camptosar INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-06-14
Marketing End Date2013-09-01

NDC 0009-7529-04 [00009752904]

Camptosar INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-06-14

NDC 0009-7529-03 [00009752903]

Camptosar INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-06-14

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:e518dfc6-7e93-4fee-a66c-51e1ab71c056
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726319
  • 1726324
  • 1726335
  • 1726321
  • 1726333
  • 1726325

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Camptosar" or generic name "Irinotecan Hydrochloride"

    NDCBrand NameGeneric Name
    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

    Trademark Results [Camptosar]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CAMPTOSAR
    CAMPTOSAR
    74544021 2030647 Live/Registered
    YAKULT HONSHA COMPANY, LTD.
    1994-06-27
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.