CEDAX - 65224-802-02 - (ceftibuten dihydrate)

Alphabetical Index


Drug Information of CEDAX

Product NDC: 65224-802
Proprietary Name: CEDAX
Non Proprietary Name: ceftibuten dihydrate
Active Ingredient(s): 90    mg/5mL & nbsp;   ceftibuten dihydrate
Administration Route(s): ORAL
Dosage Form(s): SUSPENSION
Coding System: National Drug Codes(NDC)

Labeler Information of CEDAX

Product NDC: 65224-802
Labeler Name: Pernix Therapeutics, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA050686
Marketing Category: NDA
Start Marketing Date: 19951220

Package Information of CEDAX

Package NDC: 65224-802-02
Package Description: 1 BOTTLE in 1 CARTON (65224-802-02) > 60 mL in 1 BOTTLE

NDC Information of CEDAX

NDC Code 65224-802-02
Proprietary Name CEDAX
Package Description 1 BOTTLE in 1 CARTON (65224-802-02) > 60 mL in 1 BOTTLE
Product NDC 65224-802
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ceftibuten dihydrate
Dosage Form Name SUSPENSION
Route Name ORAL
Start Marketing Date 19951220
Marketing Category Name NDA
Labeler Name Pernix Therapeutics, LLC
Substance Name CEFTIBUTEN DIHYDRATE
Strength Number 90
Strength Unit mg/5mL
Pharmaceutical Classes Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]

Complete Information of CEDAX


General Information