Doribax - 50458-401-02 - (doripenem)

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Drug Information of Doribax

Product NDC: 50458-401
Proprietary Name: Doribax
Non Proprietary Name: doripenem
Active Ingredient(s): 500    mg/10mL & nbsp;   doripenem
Administration Route(s): INTRAVENOUS
Dosage Form(s): POWDER, FOR SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Doribax

Product NDC: 50458-401
Labeler Name: Janssen Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022106
Marketing Category: NDA
Start Marketing Date: 20071012

Package Information of Doribax

Package NDC: 50458-401-02
Package Description: 10 VIAL, SINGLE-USE in 1 CARTON (50458-401-02) > 10 mL in 1 VIAL, SINGLE-USE (50458-401-01)

NDC Information of Doribax

NDC Code 50458-401-02
Proprietary Name Doribax
Package Description 10 VIAL, SINGLE-USE in 1 CARTON (50458-401-02) > 10 mL in 1 VIAL, SINGLE-USE (50458-401-01)
Product NDC 50458-401
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name doripenem
Dosage Form Name POWDER, FOR SOLUTION
Route Name INTRAVENOUS
Start Marketing Date 20071012
Marketing Category Name NDA
Labeler Name Janssen Pharmaceuticals, Inc.
Substance Name DORIPENEM
Strength Number 500
Strength Unit mg/10mL
Pharmaceutical Classes Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC]

Complete Information of Doribax


General Information