NDC 60505-6161

DORIPENEM

Doripenem

DORIPENEM is a Intravenous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Doripenem.

Product ID60505-6161_5f0c33a0-b6d8-039a-1fcd-bc3eab0f7bab
NDC60505-6161
Product TypeHuman Prescription Drug
Proprietary NameDORIPENEM
Generic NameDoripenem
Dosage FormPowder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-12-05
Marketing End Date2019-08-31
Marketing CategoryNDA / NDA
Application NumberNDA022106
Labeler NameApotex Corp.
Substance NameDORIPENEM
Active Ingredient Strength500 mg/10mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN

Packaging

NDC 60505-6161-4

10 VIAL, SINGLE-USE in 1 CARTON (60505-6161-4) > 10 mL in 1 VIAL, SINGLE-USE (60505-6161-0)
Marketing Start Date2016-12-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-6161-0 [60505616100]

DORIPENEM POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022106
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-05
Marketing End Date2019-08-31

NDC 60505-6161-4 [60505616104]

DORIPENEM POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022106
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-05
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
DORIPENEM500 mg/10mL

OpenFDA Data

SPL SET ID:fea0fab5-d29a-47ce-b34e-d6033aa9ca66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 744808
  • 1039654

    • Pharmacological Class

    • Carbapenems [CS]
    • Penem Antibacterial [EPC]

    NDC Crossover Matching brand name "DORIPENEM" or generic name "Doripenem"

    NDCBrand NameGeneric Name
    60505-6160DORIPENEMDORIPENEM
    60505-6161DORIPENEMDORIPENEM
    59630-309Doribaxdoripenem
    59630-320Doribaxdoripenem
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