Cedax - 59630-821-12 - (Ceftibuten dihydrate)

Alphabetical Index


Drug Information of Cedax

Product NDC: 59630-821
Proprietary Name: Cedax
Non Proprietary Name: Ceftibuten dihydrate
Active Ingredient(s): 18    mg/mL & nbsp;   Ceftibuten dihydrate
Administration Route(s): ORAL
Dosage Form(s): SUSPENSION
Coding System: National Drug Codes(NDC)

Labeler Information of Cedax

Product NDC: 59630-821
Labeler Name: Sciele Pharma, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA050686
Marketing Category: NDA
Start Marketing Date: 19951220

Package Information of Cedax

Package NDC: 59630-821-12
Package Description: 1 BOTTLE in 1 CARTON (59630-821-12) > 120 mL in 1 BOTTLE

NDC Information of Cedax

NDC Code 59630-821-12
Proprietary Name Cedax
Package Description 1 BOTTLE in 1 CARTON (59630-821-12) > 120 mL in 1 BOTTLE
Product NDC 59630-821
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 Sciele Pharma, Inc.
Substance Name CEFTIBUTEN DIHYDRATE
Strength Number 18
Strength Unit mg/mL
Pharmaceutical Classes Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]

Complete Information of Cedax


General Information