NDC 15054-0043

Onivyde

Irinotecan Hydrochloride

Onivyde is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Ipsen Biopharmaceuticals, Inc.. The primary component is Irinotecan Hydrochloride.

Product ID15054-0043_8d896725-9fc1-48b4-92af-17827bdc663d
NDC15054-0043
Product TypeHuman Prescription Drug
Proprietary NameOnivyde
Generic NameIrinotecan Hydrochloride
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-10-22
Marketing CategoryNDA / NDA
Application NumberNDA207793
Labeler NameIpsen Biopharmaceuticals, Inc.
Substance NameIRINOTECAN HYDROCHLORIDE
Active Ingredient Strength4 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 15054-0043-1

1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2015-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15054-0043-1 [15054004301]

Onivyde INJECTION, POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA207793
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-22

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE4.3 mg/mL

OpenFDA Data

SPL SET ID:c8b58efa-1820-48a4-b70d-62918fc4abfc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719777
  • 1719772
    • UPC Code
  • 0015054004317

    • Pharmacological Class

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