Dificid - 52015-080-02 - (fidaxomicin)

Alphabetical Index


Drug Information of Dificid

Product NDC: 52015-080
Proprietary Name: Dificid
Non Proprietary Name: fidaxomicin
Active Ingredient(s): 200    mg/1 & nbsp;   fidaxomicin
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Dificid

Product NDC: 52015-080
Labeler Name: Optimer Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA201699
Marketing Category: NDA
Start Marketing Date: 20110527

Package Information of Dificid

Package NDC: 52015-080-02
Package Description: 1 BOTTLE in 1 CARTON (52015-080-02) > 60 TABLET, FILM COATED in 1 BOTTLE

NDC Information of Dificid

NDC Code 52015-080-02
Proprietary Name Dificid
Package Description 1 BOTTLE in 1 CARTON (52015-080-02) > 60 TABLET, FILM COATED in 1 BOTTLE
Product NDC 52015-080
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name fidaxomicin
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20110527
Marketing Category Name NDA
Labeler Name Optimer Pharmaceuticals, Inc.
Substance Name FIDAXOMICIN
Strength Number 200
Strength Unit mg/1
Pharmaceutical Classes Macrolides [Chemical/Ingredient],Macrolide Antibacterial [EPC]

Complete Information of Dificid


General Information