Spectracef - 44004-802-28 - (Cefditoren Pivoxil)

Alphabetical Index


Drug Information of Spectracef

Product NDC: 44004-802
Proprietary Name: Spectracef
Non Proprietary Name: Cefditoren Pivoxil
Active Ingredient(s): 400    mg/1 & nbsp;   Cefditoren Pivoxil
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Spectracef

Product NDC: 44004-802
Labeler Name: Vansen Pharma Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021222
Marketing Category: NDA
Start Marketing Date: 20130205

Package Information of Spectracef

Package NDC: 44004-802-28
Package Description: 28 TABLET, FILM COATED in 1 BLISTER PACK (44004-802-28)

NDC Information of Spectracef

NDC Code 44004-802-28
Proprietary Name Spectracef
Package Description 28 TABLET, FILM COATED in 1 BLISTER PACK (44004-802-28)
Product NDC 44004-802
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Cefditoren Pivoxil
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20130205
Marketing Category Name NDA
Labeler Name Vansen Pharma Inc.
Substance Name CEFDITOREN PIVOXIL
Strength Number 400
Strength Unit mg/1
Pharmaceutical Classes Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]

Complete Information of Spectracef


General Information