NDC Code(s) : 60505-6245-4, 60505-6246-4
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:60505-6245
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:60505-6245-410 in 1 CARTON 09/01/2022
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 09/01/2022
CefepimeCefepime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-6246
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:60505-6246-410 in 1 CARTON 09/01/2022
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 09/01/2022

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(60505-6245, 60505-6246), analysis(60505-6245, 60505-6246)

Establishment
Name Address ID/FEI Business Operations
Qilu Antibiotics Pharmaceutical Co., Ltd. 527271779 manufacture(60505-6245, 60505-6246), analysis(60505-6245, 60505-6246)

PRINCIPAL DISPLAY PANEL

NDC 60505-6245-0 Rx Only

Cefepime

for Injection, USP

1 gram/vial

Single-Dose Vial

Reconstitute before Intramuscular Use.

Dilute before Intravenous Infusion.

P R E M I E R P r o R x ®

vial-1-gram

vial-1-gram

PRINCIPAL DISPLAY PANEL

NDC 60505-6246-0  Rx Only

Cefepime

for Injection, USP

2 grams per vial

Single-Dose Vial

Dilute before Intravenous Infusion.

P R E M I E R P r o R x ®

vial-2-gram

vial-2-gram

PRINCIPAL DISPLAY PANEL

NDC 60505-6245-4  Rx Only

Cefepime

for Injection, USP

1 gram per vial

10*1 gram Single-Dose Vials

Reconstitute before Intramuscular Use.

Dilute before Intravenous Infusion.

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

P R E M I E R P r o R x ®

carton-1-gram

carton-1-gram

PRINCIPAL DISPLAY PANEL

NDC 60505-6246-4   Rx Only

Cefepime

for Injection, USP

2 grams per vial

10*2 gram Single-Dose Vials

Dilute before Intravenous Infusion.

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

P R E M I E R P r o R x ®

carton-2-gram

carton-2-gram