NDC 59630-320

Doribax

Doripenem

Doribax is a Intravenous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Shionogi Inc.. The primary component is Doripenem.

Product ID59630-320_8879a2d9-9310-b59a-e053-2a95a90ab1c2
NDC59630-320
Product TypeHuman Prescription Drug
Proprietary NameDoribax
Generic NameDoripenem
Dosage FormPowder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-10-12
Marketing End Date2020-02-28
Marketing CategoryNDA /
Application NumberNDA022106
Labeler NameShionogi Inc.
Substance NameDORIPENEM
Active Ingredient Strength500 mg/10mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN

Packaging

NDC 59630-320-50

48 CASE in 1 CONTAINER (59630-320-50) > 228 VIAL, SINGLE-USE in 1 CASE > 10 mL in 1 VIAL, SINGLE-USE
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59630-320-01 [59630032001]

Doribax POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022106
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-12
Marketing End Date2020-02-28

NDC 59630-320-10 [59630032010]

Doribax POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022106
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-12
Marketing End Date2020-02-28

Drug Details

Active Ingredients

IngredientStrength
DORIPENEM500 mg/10mL

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

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

Trademark Results [Doribax]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DORIBAX
DORIBAX
76679238 3587574 Dead/Cancelled
SHIONOGI & CO., LTD.
2007-07-09

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