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Fortaz

Generic Name: ceftazidime sodium
Dosage Form: injection, powder, for solution

Principal Display Panel

NDC 24987-377-10

Fortaz®

(ceftazidime for injection)

500 mg

Equivalent to 500 mg of ceftazidime

For IM or IV use.

Rx only

See prescribing information for Dosage and Administration. Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution. After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Constituted solutions in Sterile Water for Injection may be frozen. See prescribing information for details. Color changes do not affect potency. This vial contains 59 mg of sodium carbonate. The sodium content is approximately 27 mg (1.2 mEq).

Dist. by Covis Pharmaceuticals, Inc.

Made in England

100035
Rev. 5/12
10000000103509

LOT
EXP
10000000103509

500 mg Vial Label

Principal Display Panel

NDC 24987-378-10

Fortaz®

(ceftazidime for injection)

1 g

Equivalent to 1 g of ceftazidime

For IM or IV use.

Rx only

See prescribing information for Dosage and Administration. Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution. After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Constituted solutions in Sterile Water for Injection may be frozen. See prescribing information for details. Color changes do not affect potency. This vial contains 118 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq).

Dist. by Covis Pharmaceuticals, Inc.

Made in England

Rev. 5/12

100037
10000000103726

LOT
EXP
10000000103726

1 g Vial Label

Principal Display Panel

NDC 24987-379-34

Fortaz®

(ceftazidime for injection)

2 g

Equivalent to 2 g of ceftazidime

For IV use.

Rx only

See prescribing information for Dosage and Administration. Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution. To prepare IV solution, add 10 mL of Sterile Water for Injection. After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Constituted solutions in Sterile Water for Injection may be frozen. See prescribing information for details. Color changes do not affect potency. This vial contains 236 mg of sodium carbonate. The sodium content is approximately 108 mg (4.7 mEq).

Dist. by Covis Pharmaceuticals, Inc.

Made in England

100031
Rev. 5/12
10000000103587

LOT
EXP
10000000103587

2 g Vial Label

Principal Display Panel

NDC 24987-382-37

Fortaz®

(ceftazidime for injection)

6 g

Equivalent to 6 g of ceftazidime

Pharmacy Bulk Package

Rx only

See package insert for Dosage and Administration. Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

IMPORTANT: The vial is under reduced pressure. Addition of diluent generates a positive pressure. Before constituting, see Instructions for Constitution.

To prepare solution, add 26 mL of Sterile Water for Injection. Shake well to dissolve. The constituted solution occupies a volume of about 31.5 mL and contains approximately 1 g of ceftazidime activity per 5 mL.

After constitution, solutions maintain potency for 12 hours at room temperature (not exceeding 25oC [77oF]) or for 3 days under refrigeration. Color changes do not affect potency. This vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq) per gram of ceftazidime.

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Made in England

10000000103768
100039
Rev. 5/12

LOT
EXP

6 g Vial Label

Principal Display Panel

NDC 24987-434-00

Fortaz®

(ceftazidime for injection)

TwistVialTM

1 g

Equivalent to 1 g of ceftazidime

For IV use.

Rx only

See prescribing information for Dosage and Administration and Instructions for Constitution.

Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

Color changes do not affect potency. This vial contains 118 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq).

Distributed by:
Covis Pharmaceuticals, Inc.
Cary, NC 27511
Made in England
Rev. 4/12

100001

10000000103171

LOT

EXP

1 g Twist/Vial Label

Principal Display Panel

NDC 54987-435-00

Fortaz®

(ceftazidime for injection)

TwistVialTM

2 g

Equivalent to 2 g of ceftazidime

For IV use.

Rx only

See prescribing information for Dosage and Administration and Instructions for Constitution.

Before constitution, store between 15o and 30oC (59o and 86oF) and protect from light.

Color changes do not affect potency. This vial contains 236 mg of sodium carbonate. The sodium content is approximately 108 mg (4.7 mEq).

Distributed by:
Covis Pharmaceuticals, Inc.
Cary, NC 27511
Made in England
Rev. 4/12

100004

10000000103176

LOT

EXP

2 g Twist/Vial Label

Fortaz 
ceftazidime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51952-016
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME (CEFTAZIDIME ANHYDROUS) CEFTAZIDIME ANHYDROUS 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
Product Characteristics
Color YELLOW (light yellow to amber) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:51952-016-00 10 VIAL, SINGLE-DOSE in 1 TRAY
1 17 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA050578 12/14/2012
Fortaz 
ceftazidime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51952-017
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME (CEFTAZIDIME ANHYDROUS) CEFTAZIDIME ANHYDROUS 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
Product Characteristics
Color YELLOW (light yellow to amber) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:51952-017-00 10 VIAL, SINGLE-DOSE in 1 TRAY
1 26 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA050578 12/14/2012
Fortaz 
ceftazidime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51952-018
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME (CEFTAZIDIME ANHYDROUS) CEFTAZIDIME ANHYDROUS 170 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
Product Characteristics
Color YELLOW (light yellow to amber) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:51952-018-00 10 VIAL, SINGLE-DOSE in 1 TRAY
1 60 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA050578 12/14/2012
Fortaz 
ceftazidime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51952-019
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME (CEFTAZIDIME ANHYDROUS) CEFTAZIDIME ANHYDROUS 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
Product Characteristics
Color YELLOW (light yellow to amber) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:51952-019-00 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY
1 127 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA050578 12/14/2012
Fortaz 
ceftazidime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51952-020
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME (CEFTAZIDIME ANHYDROUS) CEFTAZIDIME ANHYDROUS 56 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
Product Characteristics
Color YELLOW (light yellow to amber) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:51952-020-00 25 VIAL in 1 TRAY
1 18 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA050578 12/14/2012
Fortaz 
ceftazidime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51952-021
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME (CEFTAZIDIME ANHYDROUS) CEFTAZIDIME ANHYDROUS 111 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
Product Characteristics
Color YELLOW (light yellow to amber) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:51952-021-00 10 VIAL in 1 TRAY
1 18 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA050578 12/14/2012
Labeler - GlaxoSmithKline Manufacturing SpA (338773877)
Revised: 11/2017
 
GlaxoSmithKline Manufacturing SpA
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