FORTAZ- ceftazidime injection, powder, for solution 
GlaxoSmithKline Manufacturing SpA

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FORTAZ®
(ceftazidime for injection)

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 Bottle Label

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 Bottle Label

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 Bottle Label

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

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

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

2 g Twist/Vial Label

FORTAZ 
ceftazidime injection, powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51952-016
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) CEFTAZIDIME ANHYDROUS100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CARBONATE (UNII: 45P3261C7T)  
Product Characteristics
ColorYELLOW (light yellow to amber) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51952-016-0010 in 1 TRAY12/14/2012
117 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA05057812/14/2012
FORTAZ 
ceftazidime injection, powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51952-017
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) CEFTAZIDIME ANHYDROUS100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CARBONATE (UNII: 45P3261C7T)  
Product Characteristics
ColorYELLOW (light yellow to amber) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51952-017-0010 in 1 TRAY12/14/2012
126 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA05057812/14/2012
FORTAZ 
ceftazidime injection, powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51952-018
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) CEFTAZIDIME ANHYDROUS170 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CARBONATE (UNII: 45P3261C7T)  
Product Characteristics
ColorYELLOW (light yellow to amber) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51952-018-0010 in 1 TRAY12/14/2012
160 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA05057812/14/2012
FORTAZ 
ceftazidime injection, powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51952-019
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) CEFTAZIDIME ANHYDROUS200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CARBONATE (UNII: 45P3261C7T)  
Product Characteristics
ColorYELLOW (light yellow to amber) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51952-019-006 in 1 TRAY12/14/2012
1127 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA05057812/14/2012
FORTAZ 
ceftazidime injection, powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51952-020
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) CEFTAZIDIME ANHYDROUS56 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CARBONATE (UNII: 45P3261C7T)  
Product Characteristics
ColorYELLOW (light yellow to amber) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51952-020-0025 in 1 TRAY12/14/2012
118 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA05057812/14/2012
FORTAZ 
ceftazidime injection, powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51952-021
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) CEFTAZIDIME ANHYDROUS111 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CARBONATE (UNII: 45P3261C7T)  
Product Characteristics
ColorYELLOW (light yellow to amber) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51952-021-0010 in 1 TRAY12/14/2012
118 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA05057812/14/2012
Labeler - GlaxoSmithKline Manufacturing SpA (338773877)

Revised: 11/2017
 
GlaxoSmithKline Manufacturing SpA