NDC Code(s) : 36000-008-24, 36000-009-24, 36000-010-01, 36000-011-01, 36000-029-24, 36000-030-24
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CiprofloxacinCiprofloxacin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-008
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN(UNII: 5E8K9I0O4U)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)50 mg in 1 mL
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:36000-008-24100 mL in 1 BAG Type 0: Not a Combination Product08/04/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078024 08/04/2008
CiprofloxacinCiprofloxacin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-009
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN(UNII: 5E8K9I0O4U)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)50 mg in 1 mL
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:36000-009-24200 mL in 1 BAG Type 0: Not a Combination Product08/04/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078024 08/04/2008
CiprofloxacinCiprofloxacin INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-010
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN(UNII: 5E8K9I0O4U)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:36000-010-011 in 1 CARTON 17/09/2009
120 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
ANDA ANDA078062 09/17/2009 03/04/2020
CiprofloxacinCiprofloxacin INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-011
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN(UNII: 5E8K9I0O4U)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:36000-011-011 in 1 CARTON 17/09/2009
140 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
ANDA ANDA078062 09/17/2009 03/04/2020
CiprofloxacinCiprofloxacin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-029
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN(UNII: 5E8K9I0O4U)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)50 mg in 1 mL
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:36000-029-24100 mL in 1 BAG Type 0: Not a Combination Product23/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078024 10/23/2012 05/09/2018
CiprofloxacinCiprofloxacin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-030
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN(UNII: 5E8K9I0O4U)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)50 mg in 1 mL
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:36000-030-24200 mL in 1 BAG Type 0: Not a Combination Product23/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078024 10/23/2012 05/09/2018

LABELER - Baxter Healthcare Corporation(005083209)

REGISTRANT - Baxter Healthcare Corporation(005083209)

Establishment
Name Address ID/FEI Business Operations
BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED 918603338 ANALYSIS(36000-008, 36000-009, 36000-010, 36000-011, 36000-029, 36000-030), STERILIZE(36000-008, 36000-009, 36000-010, 36000-011, 36000-029, 36000-030), LABEL(36000-008, 36000-009, 36000-010, 36000-011, 36000-029, 36000-030), MANUFACTURE(36000-008, 36000-009, 36000-010, 36000-011, 36000-029, 36000-030), PACK(36000-008, 36000-009, 36000-010, 36000-011, 36000-029, 36000-030)

PRINCIPAL DISPLAY PANEL

AIN00190 NDC 36000-008-24

Ciprofloxacin in Dextrose (5%) Injection, USP

200 mg in 100 mL 5% Dextrose

Rx only     (2 mg/mL)       100 mL

INFUSE OVER A PERIOD OF 60 MINUTES

Each 100 mL contains: 200 mg Ciprofloxacin, 5 g Dextrose
Hydrous, Lactic Acid (added as solubilizer), Water for Injection,USP
pH adjusted with Hydrochloric acid. pH 3.5 to 4.6. Sterile,
nonpyrogenic. Single dose flexible plastic container.

Drug additives should not be made to this solution.

Dosage: Intravenously as directed by a physician.
See directions.

Attention Pharmacist: Dispense the accompanying
Medication Guide to each patient.

Cautions: Must not be used in series connections.

Do not use unless solution is clear.

No further dilution is necessary.

M.L.No. : G/28D/LVP/14

Manufactured for:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Manufactured by:

Baxter Pharmaceuticals India Private Ltd

Ahmedabad 382213, India

Batch No.:

Exp. Date :

ciprofloxacin-100ml-pvcbag

PRINCIPAL DISPLAY PANEL

AIN00191 NDC 36000-009-24

Ciprofloxacin in Dextrose (5%) Injection, USP

400 mg in 200 mL 5% Dextrose

Rx only      (2 mg/mL)       200 mL

INFUSE OVER A PERIOD OF 60 MINUTES

Each 100 mL contains: 200mg Ciprofloxacin, 5 g Dextrose Hydrous,
Lactic Acid (added as solubilizer), Water for Injection,USP; pH adjusted

with Hydrochloric acid. pH 3.5 to 4.6.

Sterile, nonpyrogenic. Single dose flexible plastic container.
Drug additives should not be made to this solution.

Dosage: Intravenously as directed by a physician. See directions.

Attention Pharmacist: Dispense the accompanying Medication
Guide to each patient.

Cautions: Must not be used in series connections. Do not use unless
solution is clear. No further diIution is necessary.

M.L.No. : G/28D/LVP/14

Manufactured for:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Manufactured by:

Baxter Pharmaceuticals India Private Ltd

Ahmedabad 382213, India

Batch No.:
Exp. Date :

ciprofloxacin-200ml-pvcbag

PRINCIPAL DISPLAY PANEL

AIN00197 NDC 36000-010-01      Rx Only

Ciprofloxacin Injection, USP

200 mg/20 mL

(10 mg/mL) 

ciprofloxacin-20ml-gv

PRINCIPAL DISPLAY PANEL

AIN00198 NDC 36000-011-01           Rx Only

Ciprofloxacin Injection, USP

400 mg/40 mL

(10 mg/mL)

ciprofloxacin-40ml-gv

PRINCIPAL DISPLAY PANEL

NDC 36000-029-24

Rx Only

CIPROfloxacin in Dextrose (5%) Injection, USP

200 mg in 100 mL 5% Dextrose

(2 mg/mL)

Flexible PVC Free Single Use Container is no longer available.

ciprofloxacin-100ml-npvcbag

PRINCIPAL DISPLAY PANEL

NDC 36000-030-24

CIPROfloxacin in Dextrose (5%) Injection,USP

400 mg in 200 mL 5% Dextrose

Rx Only      (2 mg/mL)

Flexible PVC Free Single Use Container no longer available.

ciprofloxacin-200ml-npvcbag