Bacteriostatic Water (Page 2 of 2)

IM-2348

Plate NDC 0409-3977-03
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Label

20 mL Multiple-dose glass vial

BACTERIOSTATIC
WATER
for Injection, USP

1.1% benzyl alcohol added.

NOT FOR USE IN NEONATES

LOT ##–###–AA

EXP DMMMYYYY

LOT/EXP Area (SVP)

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Tray

20 mL Multiple-dose glass vial

Rx only
NDC 0409-1093-04
Contains 25 of NDC 0409-1093-14

BACTERIOSTATIC WATER
for Injection, USP

WARNING:
NOT FOR USE IN NEONATES.

Each mL contains 1.1% benzyl alcohol added as a preservative.

FOR DRUG DILUENT USE ONLY.

Hospira

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Tray
(click image for full-size original)
BACTERIOSTATIC WATER
bacteriostatic water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-3977
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-3977-03 25 VIAL, MULTI-DOSE in 1 TRAY contains a VIAL, MULTI-DOSE (0409-3977-01)
1 NDC:0409-3977-01 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the TRAY (0409-3977-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018802 04/30/2005
BACTERIOSTATIC WATER
bacteriostatic water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1093
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 11 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1093-04 25 VIAL, MULTI-DOSE in 1 TRAY contains a VIAL, MULTI-DOSE (0409-1093-14)
1 NDC:0409-1093-14 20 mL in 1 VIAL, MULTI-DOSE This package is contained within the TRAY (0409-1093-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018802 04/30/2005 04/30/2005
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 827731089 ANALYSIS (0409-1093), ANALYSIS (0409-3977)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-1093), ANALYSIS (0409-3977), LABEL (0409-1093), LABEL (0409-3977), MANUFACTURE (0409-1093), MANUFACTURE (0409-3977), PACK (0409-1093), PACK (0409-3977)
Establishment
Name Address ID/FEI Operations
Pfizer Healthcare India Private Limited 860037912 ANALYSIS (0409-1093), ANALYSIS (0409-3977), LABEL (0409-1093), LABEL (0409-3977), MANUFACTURE (0409-1093), MANUFACTURE (0409-3977), PACK (0409-1093), PACK (0409-3977)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (0409-1093), ANALYSIS (0409-3977)

Revised: 11/2019 Hospira, Inc.

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