CIPROFLOXACIN (Page 13 of 13)

PRINCIPAL DISPLAY PANEL — 200 mL Bag

LOT NO.

EXP. DATE

200 mL
NDC 0409-4777-21

CIPROFLOXACIN

400 mg/200 mL (2 mg/mL)
400 mg in 200 mL
5% DEXTROSE INJ., USP

INFUSE OVER A PERIOD OF 60 MINUTES
STERILE, SINGLE-DOSE FLEXIBLE PLASTIC
CONTAINER. NONPYROGENIC. CONTAINS NO
PRESERVATIVE. SEE PACKAGE INSERT. EACH
100 mL CONTAINS: CIPROFLOXACIN 200 mg;
DEXTROSE, HYDROUS 5 g; LACTIC ACID ADDED
AS SOLUBILIZER; WATER FOR INJECTION, USP;
HYDROCHLORIC ACID FOR pH ADJUSTMENT
3.5 TO 4.6. DO NOT ADMIX WITH OTHER DRUGS
OR ADDITIVES. FOR COMPLETE PRODUCT
INFORMATION INCLUDING DOSAGE AND
ADMINISTRATION, SEE ACCOMPANYING
PACKAGE INSERT. USE ONLY IF SOLUTION IS
CLEAR AND CONTAINER IS UNDAMAGED.
MUST NOT BE USED IN SERIES CONNECTIONS.

RX ONLY

3
V
CONTAINS DEHP

Hospira

DISTRIBUTED
BY HOSPIRA, INC.,
LAKE FOREST,
IL 60045 USA

14521901IM-4459

PRINCIPAL DISPLAY PANEL -- 200 mL Bag
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mL Bag Pouch

TO OPEN — TEAR AT NOTCH
ONE UNIT / NDC 0409-4777-21

CIPROFLOXACIN

400 mg/200 mL (2 mg/mL)
400 mg in 200 mL
5% DEXTROSE INJ., USP

ATTENTION PHARMACIST: DISPENSE THE ACCOMPANYING
MEDICATION GUIDE TO EACH PATIENT

INFUSE OVER A PERIOD OF 60 MINUTES
STERILE, SINGLE-DOSE FLEXIBLE PLASTIC CONTAINER.
NONPYROGENIC. CONTAINS NO PRESERVATIVE. EACH 100 mL
CONTAINS: CIPROFLOXACIN 200 mg; DEXTROSE, HYDROUS
5 g; LACTIC ACID, ADDED AS SOLUBILIZER; WATER FOR
INJECTION, USP; HYDROCHLORIC ACID FOR pH ADJUSTMENT
(pH 3.5 TO 4.6). FOR COMPLETE PRODUCT INFORMATION
INCLUDING DOSAGE AND ADMINISTRATION, SEE
ACCOMPANYING PACKAGE INSERT. USE ONLY IF SOLUTION
IS CLEAR. AFTER REMOVING THE OVERWRAP, CHECK FOR
MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS
ARE FOUND, DISCARD UNIT AS STERILITY MAY BE IMPAIRED.
MUST NOT BE USED IN SERIES CONNECTIONS. DO NOT
ADMIX WITH OTHER DRUGS OR ADDITIVES. THE OVERWRAP
IS A MOISTURE BARRIER. DO NOT REMOVE UNIT FROM
OVERWRAP UNTIL READY FOR USE. USE UNIT PROMPTLY
WHEN POUCH IS OPENED. STORE AT 20 TO 25°C (68 TO 77°F).
[SEE USP CONTROLLED ROOM TEMPERATURE.] MAY ALSO
REFRIGERATE (SEE INSERT). PROTECT FROM FREEZING.
PROTECT FROM LIGHT. SEE PACKAGE INSERT.

Not Made With Natural Rubber Latex

RX ONLY

7
OTHER

14522001
F WR-0574

DISTRIBUTED BY
HOSPIRA, INC., LAKE FOREST, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 200 mL Bag Pouch
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL Bag

100 mL
NDC NDC 0409-4777-11

CIPROFLOXACIN

200 mg/100 mL (2 mg/mL)
200 mg in 100 mL
5% DEXTROSE INJ., USP

INFUSE OVER A PERIOD OF 60 MINUTES
STERILE, SINGLE-DOSE FLEXIBLE PLASTIC CONTAINER.
NONPYROGENIC. CONTAINS NO PRESERVATIVE. SEE
PACKAGE INSERT. EACH 100 mL CONTAINS:
CIPROFLOXACIN 200 mg; DEXTROSE, HYDROUS 5 g;
LACTIC ACID ADDED AS SOLUBILIZER; WATER FOR
INJECTION, USP; HYDROCHLORIC ACID FOR pH
ADJUSTMENT 3.5 TO 4.6. DO NOT ADMIX WITH OTHER
DRUGS OR ADDITIVES. FOR COMPLETE PRODUCT
INFORMATION INCLUDING DOSAGE AND
ADMINISTRATION, SEE ACCOMPANYING PACKAGE
INSERT. USE ONLY IF SOLUTION IS CLEAR AND
CONTAINER IS UNDAMAGED. MUST
NOT BE USED IN SERIES CONNECTIONS.

Rx ONLY

3
V
CONTAINS DEHP

DISTRIBUTED BY
HOSPIRA, INC.,
LAKE FOREST,
IL 60045 USA

14521401IM-4458

PRINCIPAL DISPLAY PANEL -- 100 mL Bag
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL Bag Pouch

TO OPEN — TEAR AT NOTCH
ONE UNIT / NDC 0409-4777-11

CIPROFLOXACIN

200 mg/100 mL (2 mg/mL)
200 mg in 100 mL
5% DEXTROSE INJ., USP

ATTENTION PHARMACIST: DISPENSE THE ACCOMPANYING
MEDICATION GUIDE TO EACH PATIENT

INFUSE OVER A PERIOD OF 60 MINUTES
STERILE, SINGLE-DOSE FLEXIBLE PLASTIC CONTAINER. NONPYROGENIC. CONTAINS NO
PRESERVATIVE. EACH 100 mL CONTAINS: CIPROFLOXACIN 200 mg; DEXTROSE, HYDROUS 5 g;
LACTIC ACID, ADDED AS SOLUBILIZER; WATER FOR INJECTION, USP; HYDROCHLORIC ACID FOR
pH ADJUSTMENT (pH 3.5 TO 4.6). FOR COMPLETE PRODUCT INFORMATION INCLUDING DOSAGE
AND ADMINISTRATION, SEE ACCOMPANYING PACKAGE INSERT. USE ONLY IF SOLUTION IS
CLEAR. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING
CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD UNIT AS STERILITY MAY BE IMPAIRED.
MUST NOT BE USED IN SERIES CONNECTIONS. DO NOT ADMIX WITH OTHER DRUGS OR
ADDITIVES. THE OVERWRAP IS A MOISTURE BARRIER. DO NOT REMOVE UNIT FROM OVERWRAP
UNTIL READY FOR USE. USE UNIT PROMPTLY WHEN POUCH IS OPENED. STORE AT 20 to 25°C
(68 to 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] MAY ALSO REFRIGERATE (SEE
INSERT). PROTECT FROM FREEZING. PROTECT FROM LIGHT. SEE PACKAGE INSERT.

Not Made With Natural Rubber Latex

RX ONLY

7
OTHER

Hospira

DISTRIBUTED BY
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

14521501F WR-0573

PRINCIPAL DISPLAY PANEL -- 100 mL Bag Pouch
(click image for full-size original)
CIPROFLOXACIN ciprofloxacin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4777
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN (CIPROFLOXACIN) CIPROFLOXACIN 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE
LACTIC ACID, UNSPECIFIED FORM
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4777-02 24 POUCH in 1 CASE contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CASE (0409-4777-02) and contains a BAG (0409-4777-21)
1 NDC:0409-4777-21 200 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-4777-02)
2 NDC:0409-4777-23 24 POUCH in 1 CASE contains a POUCH
2 1 BAG in 1 POUCH This package is contained within the CASE (0409-4777-23) and contains a BAG (0409-4777-11)
2 NDC:0409-4777-11 100 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-4777-23)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077753 03/19/2008
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (0409-4777)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-4777)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 827731089 ANALYSIS (0409-4777)

Revised: 03/2020 Hospira, Inc.

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