Ceftriaxone (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 g Vial Label

NDC 65862-137-01

Single-Use Vial

Ceftriaxone for Injection, USP

1 g/vial

Rx only For I.M. or I.V. Use

AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1 g Vial Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 g Box (25 Vial)

NDC 65862-137-01

Ceftriaxone for Injection, USP

1 g/vial

Rx only 25 Single Use Vials For I.M. or I.V. Use

AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1 g Box (25 Vial)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2 g Vial Label

NDC 65862-138-02

Single-Use Vial

Ceftriaxone for Injection, USP

2 g/vial

Rx only For I.M. or I.V. Use

AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2 g Vial Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2 g Box (25 Vial)

NDC 65862-138-02

Ceftriaxone for Injection, USP

2 g/vial

Rx only 25 Single Use Vials For I.M. or I.V. Use

AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2 g Box (25 Vial)
(click image for full-size original)
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-135
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:65862-135-25 25 VIAL (25 VIAL) in 1 BOX contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION (1 VIAL) in 1 VIAL This package is contained within the BOX (65862-135-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065505 07/31/2008
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-136
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:65862-136-05 25 VIAL (25 VIAL) in 1 BOX contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION (1 VIAL) in 1 VIAL This package is contained within the BOX (65862-136-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065505 07/31/2008
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-137
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:65862-137-01 25 VIAL (25 VIAL) in 1 BOX contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION (1 VIAL) in 1 VIAL This package is contained within the BOX (65862-137-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065505 07/31/2008
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-138
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:65862-138-02 25 VIAL (25 VIAL) in 1 BOX contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION (1 VIAL) in 1 VIAL This package is contained within the BOX (65862-138-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065505 07/31/2008
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917639 MANUFACTURE, API MANUFACTURE, ANALYSIS

Revised: 07/2011 Aurobindo Pharma Limited

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