NDC Code(s) : 60505-6142-0, 60505-6142-5, 60505-6231-0, 60505-6231-5, 60505-6266-0, 60505-6266-5
Packager : Apotex Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CefazolinCefazolin INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-6142
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFAZOLIN SODIUM(UNII: P380M0454Z)
(CEFAZOLIN - UNII:IHS69L0Y4T) 		CEFAZOLIN1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-6142-525 in 1 CARTON 30/06/2017
1NDC:60505-6142-01 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 ANDA203661 06/30/2017
CefazolinCefazolin INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-6231
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFAZOLIN SODIUM(UNII: P380M0454Z)
(CEFAZOLIN - UNII:IHS69L0Y4T) 		CEFAZOLIN2 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-6231-525 in 1 CARTON 18/03/2022
1NDC:60505-6231-01 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 ANDA203661 03/18/2022
CefazolinCefazolin INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-6266
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFAZOLIN SODIUM(UNII: P380M0454Z)
(CEFAZOLIN - UNII:IHS69L0Y4T) 		CEFAZOLIN3 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-6266-525 in 1 CARTON 13/02/2024
1NDC:60505-6266-01 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 ANDA203661 02/13/2024

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(60505-6142, 60505-6231, 60505-6266), analysis(60505-6142, 60505-6231, 60505-6266)

Establishment
Name Address ID/FEI Business Operations
Qilu Antibiotics Pharmaceutical Co., Ltd. 527271779 manufacture(60505-6142, 60505-6231), analysis(60505-6142, 60505-6231)

PRINCIPAL DISPLAY PANEL

NDC 60505-6142-0

Cefazolin for Injection, USP

1 gram/vial

For IM or IV Use

Rx Only

APOTEX CORP.

1 g vial label-high-tech

1 g vial label-high-tech

PRINCIPAL DISPLAY PANEL

25* 1 gram Vials    NDC 60505-6142-5

Cefazolin for Injection, USP

1 gram/vial

For Intramuscular or Intravenous Use

PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE

APOTEX  CORP.

1 g carton label-high-tech

1 g carton label-high-tech

PRINCIPAL DISPLAY PANEL

NDC 60505-6231-0

Cefazolin for Injection, USP

2 grams/vial

For IM or IV Use

Rx Only

APOTEX CORP.

2 g vial label-high-tech

2 g vial label-high-tech

PRINCIPAL DISPLAY PANEL

25* 2 grams Vials NDC 60505-6231-5

Cefazolin for Injection, USP

2 grams/vial

For Intramuscular or Intravenous Use

PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE

Rx Only

APOTEX CORP.

2 g carton label-high-tech

2 g carton label-high-tech

PRINCIPAL DISPLAY PANEL

NDC 60505-6266-0

Cefazolin for Injection, USP

3 grams/vial

For IM or IV Use

Rx Only

APOTEX CORP.

3g vial label

PRINCIPAL DISPLAY PANEL

25* 3 grams Vials NDC 60505-6266-5

Cefazolin for Injection, USP

3 grams/vial

For Intramuscular or Intravenous Use

PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE

Rx Only

APOTEX CORP.

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