NDC Code(s) : 60505-6144-4, 60505-6145-4
Packager : Apotex Corp.

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:60505-6144
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:60505-6144-410 in 1 CARTON 14/11/2017
11 in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203704 11/14/2017
CefepimeCefepime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-6145
Route of Administration INTRAVENOUS 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:60505-6145-410 in 1 CARTON 14/11/2017
11 in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203704 11/14/2017

LABELER - Apotex Corp.(845263701)

REGISTRANT - Qilu Pharmaceutical Co., Ltd.(653878256)

Establishment
Name Address ID/FEI Business Operations
Qilu Pharmaceutical Co., Ltd. (High-Tech Zone Site) 421279342 manufacture(60505-6144, 60505-6145), analysis(60505-6144, 60505-6145)

Establishment
Name Address ID/FEI Business Operations
Qilu Antibiotics Pharmaceutical Co., Ltd. 527271779 manufacture(60505-6144, 60505-6145), analysis(60505-6144, 60505-6145)

PRINCIPAL DISPLAY PANEL

Single-Dose Vial NDC 60505-6144-0

Cefepime for Injection, USP

1 gram per vial

Reconstitute before Intramuscular Use.

Dilute before Intravenous Infusion.

Rx Only

NOVAPLUS®

vial-1-gram

vial-1-gram

PRINCIPAL DISPLAY PANEL

Single-Dose Vial NDC 60505-6145-0

Cefepime for Injection, USP

2 grams per vial

Dilute before Intravenous Infusion.

Rx Only

NOVAPLUS®

vial-2-gram

vial-2-gram

PRINCIPAL DISPLAY PANEL

10*1 gram Single-Dose Vials NDC 60505-6144-4

Cefepime for Injection, USP

1 gram per vial

Reconstitute before Intramuscular Use.

Dilute before Intravenous Infusion.

Protect from Light. Retain in Carton Until Time of Use.

Rx Only

NOVAPLUS®

carton-1-gram

carton-1-gram

PRINCIPAL DISPLAY PANEL

10*2 gram Single-Dose Vials NDC 60505-6145-4

Cefepime for Injection, USP

2 grams per vial

Dilute before Intravenous Infusion.

Protect from Light. Retain in Carton Until Time of Use.

Rx Only

NOVAPLUS®

carton-2-gram

carton-2-gram