NDC 69171-398

Onivyde

Irinotecan Hydrochloride

Onivyde is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Merrimack Pharmaceuticals. The primary component is Irinotecan Hydrochloride.

Product ID69171-398_48fd1914-58ad-4bee-92a3-7e3532642d2e
NDC69171-398
Product TypeHuman Prescription Drug
Proprietary NameOnivyde
Generic NameIrinotecan Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-10-22
Marketing End Date2019-09-30
Marketing CategoryNDA / NDA
Application NumberNDA207793
Labeler NameMerrimack Pharmaceuticals
Substance NameIRINOTECAN HYDROCHLORIDE
Active Ingredient Strength4 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 69171-398-01

10 mL in 1 VIAL (69171-398-01)
Marketing Start Date2015-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69171-398-01 [69171039801]

Onivyde INJECTION
Marketing CategoryNDA
Application NumberNDA207793
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-22
Marketing End Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE4.3 mg/mL

OpenFDA Data

SPL SET ID:52ef5879-4cb5-443a-a355-5de14c497f22
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719777
  • 1719772
    • UPC Code
  • 0069171398019

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    15054-0043OnivydeIRINOTECAN HYDROCHLORIDE
    69171-398OnivydeOnivyde
    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

    Trademark Results [Onivyde]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ONIVYDE
    ONIVYDE
    85971097 4874816 Live/Registered
    Merrimack Pharmaceuticals, Inc.
    2013-06-26
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.