NDC Code(s) : 0069-3241-15, 0069-3241-22, 0069-3342-15, 0069-3342-22, 0069-4395-19, 0069-4396-27
Packager : Pfizer Labs, Division of Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-3241
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(UNII: 33X04XA5AT)
Hydrochloric Acid(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-3241-2210 in 1 CASE
1NDC:0069-3241-151 in 1 CARTON
120 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078062 09/11/2009
Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-3342
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(UNII: 33X04XA5AT)
Hydrochloric Acid(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-3342-2210 in 1 CASE
1NDC:0069-3342-151 in 1 CARTON
140 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078062 09/11/2009
Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4395
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(UNII: IY9XDZ35W2)50 mg in 1 mL
LACTIC ACID(UNII: 33X04XA5AT)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4395-19100 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078024 09/11/2009
Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4396
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(UNII: IY9XDZ35W2)50 mg in 1 mL
LACTIC ACID(UNII: 33X04XA5AT)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4396-27200 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078024 09/11/2009

PRINCIPAL DISPLAY PANEL

TO OPEN - TEAR AT NOTCH

Ciprofloxacin in Dextrose (5%) Injection

200 mg in 100 mL 5% Dextrose

Rx only (2 mg/mL)       100 mL

N 103 0069439519 0

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 additves should not be made to this solution

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

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

Cautions:Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution as sterility may be impaired

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

Recommended storage: Store between (5-25°C) (41°-77°F). Avoid excessive heat. Protect from freezing. Protect from light. See package insert.

Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture and light barrier. The inner bag maintains the sterility of the product.

M.L. No.: GUJ/DRUGS/G/LVP-5

Disctributed by
Pfizer Labs
Division of Pfizer, Inc, NY, NY, 10017
1000004444
Made in India

Ciprofloxacin in Dextrose (5%) Injection 100 mL Overwrap Label

PRINCIPAL DISPLAY PANEL

TO OPEN - TEAR AT NOTCH

Ciprofloxacin in Dextrose (5%) Injection

400 mg in 200 mL 5% Dextrose

Rx only (2 mg/mL)       200 mL

N 10300694396272

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 additves should not be made to this solution

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

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

Cautions:Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution as sterility may be impaired

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

Recommended storage: Store between (5-25°C) (41°-77°F). Avoid excessive heat. Protect from freezing. Protect from light. See package insert.

Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture and light barrier. The inner bag maintains the sterility of the product.

M.L. No.: GUJ/DRUGS/G/LVP-5

Disctributed by
Pfizer Labs
Division of Pfizer, Inc, NY, NY, 10017
1000004447
Made in India

Ciprofloxacin in Dextrose (5%) Injection 200 mL Overwrap Label

PRINCIPAL DISPLAY PANEL

Ciprofloxacin Injection, USP

200 mg/20 mL

(10 mg/mL) 

For intravenous (I.V.) Infusion

SINGLE DOSE VIAL contains:
20 mL sterile 1% solution

200 mg ciprofloxacin

DILUTE BEFORE USE

Rx Only

Ciprofloxacin Injection, USP 20 mL Container Label

PRINCIPAL DISPLAY PANEL

NDC 0069-3241-15
11 22

Ciprofloxacin Injection, USP

200 mg/ 20 mL

(10 mg/mL) 

For intravenous (I.V.) Infusion

Rx Only

DILUTE BEFORE USE

Ciprofloxacin Injection, USP 20 mL Carton

PRINCIPAL DISPLAY PANEL

Ciprofloxacin Injection, USP

400 mg/40 mL

(10 mg/mL) 

For intravenous (I.V.) Infusion

SINGLE DOSE VIAL contains:
40 mL sterile 1% solution

400 mg ciprofloxacin

DILUTE BEFORE USE

Rx Only

Ciprofloxacin Injection, USP 40 mL Container Label

PRINCIPAL DISPLAY PANEL

NDC 0069-3342-15
11 22

Ciprofloxacin Injection, USP

400 mg/ 40 mL

(10 mg/mL) 

For intravenous (I.V.) Infusion

Rx Only

DILUTE BEFORE USE

Ciprofloxacin Injection, USP 40 mL Carton