CEFTRIAXONE: Package Insert and Label Information (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CEFTRIAXONE FOR INJECTION USP

250 mg

Rx Only

NDC 68180-611-01

1 VIAL In 1 BOX

CEFTRIAXONE FOR INJECTION USP
250 mg 
Rx Only
NDC 68180-611-01
							1 VIAL In 1 BOX
(click image for full-size original)

CEFTRIAXONE FOR INJECTION USP

500 mg

Rx Only

NDC 68180-622-01

1 VIAL In 1 BOX

CEFTRIAXONE FOR INJECTION USP
500 mg 
Rx Only
NDC 68180-622-01
							1 VIAL In 1 BOX
(click image for full-size original)

CEFTRIAXONE FOR INJECTION USP

1 g

Rx Only

NDC 68180-633-01

1 VIAL In 1 BOX

CEFTRIAXONE FOR INJECTION USP
1 g 
Rx Only
NDC 68180-633-01
							1 VIAL In 1 BOX
(click image for full-size original)

CEFTRIAXONE FOR INJECTION USP

2 g

Rx Only

NDC 68180-644-01

1 VIAL In 1 BOX

CEFTRIAXONE FOR INJECTION USP
2 g 
Rx Only
NDC 68180-644-01
							1 VIAL In 1 BOX
(click image for full-size original)
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-611
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 250 mg
Product Characteristics
Color WHITE (white to yellowish orange) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-611-01 1 INJECTION, POWDER, FOR SOLUTION in 1 BOX None
2 NDC:57297-611-10 10 INJECTION, POWDER, FOR SOLUTION in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065125 06/01/2009
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-622
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 500 mg
Product Characteristics
Color WHITE (white to yellowish orange) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-622-10 10 INJECTION, POWDER, FOR SOLUTION in 1 BOX None
2 NDC:57297-622-01 1 INJECTION, POWDER, FOR SOLUTION in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065125 06/01/2009
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-633
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 1 g
Product Characteristics
Color WHITE (white to yellowish orange) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-633-01 1 INJECTION, POWDER, FOR SOLUTION in 1 BOX None
2 NDC:57297-633-10 10 INJECTION, POWDER, FOR SOLUTION in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065125 06/01/2009
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-644
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 2 g
Product Characteristics
Color WHITE (white to yellowish orange) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-644-10 10 INJECTION, POWDER, FOR SOLUTION in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065125 06/01/2009
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 725504448 manufacture (57297-611), manufacture (57297-622), manufacture (57297-633), manufacture (57297-644), pack (57297-611), pack (57297-622), pack (57297-633), pack (57297-644)

Revised: 05/2016 LUPIN LIMITED

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