Cefotaxime (Page 4 of 4)

HOW SUPPLIED

Sterile Cefotaxime for injection, USP is a dry off-white to pale yellow crystalline powder supplied in vials containing cefotaxime sodium as follows:

500 mg cefotaxime (free acid equivalent) in vials in packages of:

Package of 1 NDC 64679-947-01

Package of 10 NDC 64679-947-02

1 g cefotaxime (free acid equivalent) in vials in packages of:

Package of 1 NDC 64679-986-01

Package of 10 NDC 64679-986-02

Package of 25 NDC 64679-986-03

Package of 50 NDC 64679-986-04

2 g cefotaxime (free acid equivalent) in vials in packages of:

Package of 1 NDC 64679-948-01

Package of 10 NDC 64679-948-02

NOTE: Cefotaxime for injection, USP in the dry state, store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light.

REFERENCES

1. Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31-41, 1976.

Travasol® is registered trademark of Baxter International Inc.

Rx only

Manufactured by:

Wockhardt Limited

Plot No.B-15/2, M.I.D.C. Area,

Waluj, Aurangabad,

Maharashtra, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054,

USA.

Rev.210518

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Cefotaxime Sodium

GENERIC: Cefotaxime Sodium

DOSAGE: Injection

ADMINSTRATION: Intramuscular, Intravenous

NDC: 64679-986-01

STRENGTH: 1 g per vial

QTY: Single Use Vial Label

1g-vial label
(click image for full-size original)

DRUG: Cefotaxime Sodium

GENERIC: Cefotaxime Sodium

DOSAGE: Injection

ADMINSTRATION: Intramuscular, Intravenous

NDC: 64679-986-01

STRENGTH: 1 g per vial

QTY: Single Dose Vial carton

1g-mono carton
(click image for full-size original)

DRUG: Cefotaxime Sodium

GENERIC: Cefotaxime Sodium

DOSAGE: Injection

ADMINSTRATION: Intramuscular, Intravenous

NDC: 64679-948-01

STRENGTH: 2 g per vial

QTY: Single Dose Vial Label

2-g-vial label
(click image for full-size original)
CEFOTAXIME cefotaxime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-947
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFOTAXIME SODIUM (CEFOTAXIME) CEFOTAXIME 500 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-947-01 1 CARTON in 1 CARTON contains a CARTON
1 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-947-01)
2 NDC:64679-947-02 10 CARTON in 1 CARTON contains a CARTON
2 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-947-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065197 06/20/2008
CEFOTAXIME cefotaxime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-986
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFOTAXIME SODIUM (CEFOTAXIME) CEFOTAXIME 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-986-01 1 CARTON in 1 CARTON contains a CARTON
1 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-986-01)
2 NDC:64679-986-02 10 CARTON in 1 CARTON contains a CARTON (64679-986-01)
2 NDC:64679-986-01 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-986-02)
3 NDC:64679-986-03 25 CARTON in 1 CARTON contains a CARTON (64679-986-01)
3 NDC:64679-986-01 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-986-03)
4 NDC:64679-986-04 50 CARTON in 1 CARTON contains a CARTON (64679-986-01)
4 NDC:64679-986-01 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-986-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065197 08/29/2008
CEFOTAXIME cefotaxime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-948
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFOTAXIME SODIUM (CEFOTAXIME) CEFOTAXIME 2 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-948-01 1 CARTON in 1 CARTON contains a CARTON
1 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-948-01)
2 NDC:64679-948-02 10 CARTON in 1 CARTON contains a CARTON (64679-948-01)
2 NDC:64679-948-01 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON This package is contained within the CARTON (64679-948-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065197 06/20/2008
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt USA LLC. (170508365)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 915122332 ANALYSIS (64679-947), ANALYSIS (64679-986), ANALYSIS (64679-948), MANUFACTURE (64679-947), MANUFACTURE (64679-986), MANUFACTURE (64679-948), LABEL (64679-947), LABEL (64679-986), LABEL (64679-948), PACK (64679-947), PACK (64679-986), PACK (64679-948)

Revised: 11/2019 Wockhardt USA LLC.

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