NDC Code(s) : 24987-352-10, 24987-354-10, 24987-400-00, 24987-436-00, 24987-437-00, 24987-425-00
Packager : Covis Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZINACEFcefuroxime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-352
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME SODIUM(UNII: R8A7M9MY61)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME90 mg in 1 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-352-1010 in 1 TRAY
18.3 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050558 01/15/2013
ZINACEFcefuroxime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-354
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME SODIUM(UNII: R8A7M9MY61)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME90 mg in 1 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-354-1010 in 1 TRAY
116 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050558 01/15/2013
ZINACEFcefuroxime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-400
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME SODIUM(UNII: R8A7M9MY61)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME90 mg in 1 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-400-006 in 1 TRAY
177 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050558 01/15/2013
ZINACEFcefuroxime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-436
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME SODIUM(UNII: R8A7M9MY61)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME90 mg in 1 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-436-0025 in 1 TRAY
18.3 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050558 01/15/2013
ZINACEFcefuroxime INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-437
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME SODIUM(UNII: R8A7M9MY61)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME90 mg in 1 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-437-0010 in 1 TRAY
116 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050558 01/15/2013
ZINACEFcefuroxime INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-425
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME SODIUM(UNII: R8A7M9MY61)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME1.5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE(UNII: IY9XDZ35W2)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Product Characteristics
Color YELLOW (light yellow to amber) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-425-0024 in 1 CARTON
150 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050643 10/15/2012

PRINCIPAL DISPLAY PANEL

NDC 24987-352-10

Zinacef ®
(cefuroxime for injection)

750 mg

Equivalent to 750 mg of Cefuroxime Activity.

For IM or IV use.

Rx only

See accompanying prescribing information for Dosage and Administration. Store between 15o and 30oC (59o and 86oF). Protect from light.

To prepare IM suspension, add 3.0 mL of Sterile Water for Injection. Shake gently to disperse and withdraw completely the resulting suspension for injection. The resulting concentration is approximately 225 mg/mL.

To prepare IV solution, add 8.3 mL of Sterile Water for Injection. Shake until dissolved and withdraw completely the resulting solution for injection.

After constitution, the suspension and solution maintain potency for 24 hours at room temperature or 48 hours under refrigeration (5oC). Color changes do not affect potency.

Dist. by Covis Pharmaceuticals, Inc.

Made in England

1000040

Rev. 5/12

10000000103766

750 mg Vial Label750 mg Vial Label

PRINCIPAL DISPLAY PANEL

NDC 24987-0354-10

Zinacef ®
(cefuroxime for injection)

1.5 g

Equivalent to 1.5 g of Cefuroxime Activity.

For IV use.

Rx only

See accompanying prescribing prescribing information for Dosage and Administration.

Store between 15o and 30oC (59o and 86oF). Protect from light.

To prepare IV solution, add 16.0 mL of Sterile Water for Injection. Shake until dissolved and withdraw completely for injection.

After constitution, the solution maintains potency for 24 hours at room temperature or 48 hours under refrigeration (5oC). Color changes in solution do not affect potency.

Dist. by Covis Pharmaceuticals, Inc.

Made in England

100042

Rev. 5/12

10000000103761

1.5 g Vial Label1.5 g Vial Label

PRINCIPAL DISPLAY PANEL

NDC 24987-400-00

Zinacef ®
(cefuroxime for injection)

7.5 g

Equivalent to 7.5 g of Cefuroxime Activity.

Pharmacy Bulk Package – Not for Direct Infusion

Rx only

10000000103728

See accompanying prescribing information for Dosage and Administration.

Store between 15o and 30oC (59o and 86oF). Protect from light.

To prepare solution, add 77 mL of Sterile Water for Injection. Shake well to dissolve. The constituted solution occupies a volume of about 82.5 mL and contains approximately 750 mg of cefuroxime activity per 8 mL.

After constitution, the solution maintains potency for 24 hours at room temperature or 7 days under refrigeration (5°C). Dispense aliquots from the vial via a suitable dispensing device into infusion fluids under a laminar flow hood using aseptic technique. DISCARD VIAL WITHIN 24 HOURS AFTER INITIAL WITHDRAWAL.

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511

Made in England

10000000103728

100044

Rev. 5/12

7.5 g Pharmacy Bulk Label7.5 g Pharmacy Bulk Label

PRINCIPAL DISPLAY PANEL

NDC 24987-436-00

Zinacef®
(cefuroxime for injection)

TwistVialTM

750 mg

Equivalent to 750 mg of Cefuroxime Activity.

For IV use.

Rx only

See accompanying 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.

Distributed by:

Covis Pharmaceuticals, Inc.
Cary, NC 27511

Made in England

Rev. 4/12

100006

10000000103141

750 mg TwistVial Label750 mg TwistVial Label

PRINCIPAL DISPLAY PANEL

NDC 24987-437-00

Zinacef®
(cefuroxime for injection)

TwistVialTM

1.5 g

Equivalent to 1.5 g of Cefuroxime Activity.

For IV use.

Rx only

See accompanying 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.

Distributed by:

Covis Pharmaceuticals, Inc.
Cary, NC 27511

Made in England

Rev. 4/12

100009

10000000103144

1.5 g TwistVial Label1.5 g TwistVial Label

PRINCIPAL DISPLAY PANEL

Zinacef® (cefuroxime injection)

12 - 50 mL Single-Dose Containers ISO-osmotic

Do not store above -20oC. Do Not Refreeze.

1.5 g

Covis Pharmaceuticals, Inc.
Cary, NC 27511

Covis

NDC 24987-425-00

Code 2G3547

(01) 20324987425002

Galaxy Container

Sterile, Nonpyrogenic

Each 50 mL contains: cefuroxime sodium equivalent to 1.5 g of cefuroxime with 600 mg of sodium citrate hydrous, USP added as a buffer. pH adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. pH 5.0 to 7.5.

Dosage: Intravenously as directed by a physician. See accompanying prescribing information.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

Rx only

Do not store above -20oC. Thaw at room temperature (25oC) or under refrigeration (5oC). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution is stable for 28 days under refrigeration or 24 hours at room temperature. Do not refreeze.

Zinacef is a registered trademark of GlaxoSmithKline
Galaxy is a registered trademark of Baxter International Inc.
Dist. by Covis Pharmaceuticals, Inc., Cary, NC 27511
Mfd. by Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Made in England

PL 2040 Plastic

100019

07-04-68-551

Rev. 5/12

1.5 g Galaxy Single-Dose Label1.5 g Galaxy Single-Dose Label