NDC Code(s) : 60505-0678-0, 60505-0678-1, 60505-0678-4, 60505-0834-0, 60505-0834-1, 60505-0834-4, 60505-0681-0, 60505-0681-1, 60505-0681-4
Packager : Apotex Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CEFEPIMECefepime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0678
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFEPIME HYDROCHLORIDE(UNII: I8X1O0607P)
(CEFEPIME - UNII:807PW4VQE3) 		CEFEPIME500 mg
Inactive Ingredients
Ingredient Name Strength
ARGININE(UNII: 94ZLA3W45F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-0678-01 in 1 CARTON 18/06/2007
11 in 1 VIAL Type 0: Not a Combination Product
2NDC:60505-0678-410 in 1 CARTON 18/06/2007
2NDC:60505-0678-11 in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065369 06/18/2007 04/09/2013
CEFEPIMECefepime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0834
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFEPIME HYDROCHLORIDE(UNII: I8X1O0607P)
(CEFEPIME - UNII:807PW4VQE3) 		CEFEPIME1 g
Inactive Ingredients
Ingredient Name Strength
ARGININE(UNII: 94ZLA3W45F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-0834-01 in 1 CARTON 18/06/2007
11 in 1 VIAL Type 0: Not a Combination Product
2NDC:60505-0834-410 in 1 CARTON 18/06/2007
2NDC:60505-0834-11 in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065369 06/18/2007
CEFEPIMECefepime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0681
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFEPIME HYDROCHLORIDE(UNII: I8X1O0607P)
(CEFEPIME - UNII:807PW4VQE3) 		CEFEPIME2 g
Inactive Ingredients
Ingredient Name Strength
ARGININE(UNII: 94ZLA3W45F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-0681-01 in 1 CARTON 18/06/2007
11 in 1 VIAL Type 0: Not a Combination Product
2NDC:60505-0681-410 in 1 CARTON 18/06/2007
2NDC:60505-0681-11 in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065369 06/18/2007

PRINCIPAL DISPLAY PANEL

NDC 60505-0678

PRINCIPAL DISPLAY PANEL

Single-Dose Vial
NDC 60505-0834-1

Cefepime
for Injection, USP

1 gram*

For IV or IM Use
after constitution.

Rx Only

APOTEX CORP.

Principal Display Panel - 1 gram Vial Label

PRINCIPAL DISPLAY PANEL

Carton NDC 60505-0834-0

 
949119430

Carton NDC 60505-0834-0

PRINCIPAL DISPLAY PANEL

Single-Dose Vial
NDC 60505-0681-1

Cefepime
for Injection, USP

2 grams*

For IV Use
after constitution.

Rx Only

APOTEX CORP.

Principal Display Panel - 2 gram Vial Label

PRINCIPAL DISPLAY PANEL

Carton NDC 60505-0681-0

 

949119431
 

Carton NDC 60505-0681-0