Sterile Water (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label — NDC 0409-4887-17

10 mL Single-dose

Sterile Water
for Injection, USP

FOR DRUG DILUENT USE

LOT ##-###-AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 10 mL Vial Tray — NDC 0409-4887-10

10 mL Single-dose

Rx only
NDC 0409-4887-10Contains 25 of NDC 0409-4887-17

Sterile Water for Injection, USP

FOR DRUG DILUENT USE

Hospira

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label — NDC 0409-4887-32

10 mL Single-dose

Sterile Water
for Inj., USP

Rx only

Hospira

LOT ##-###-AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 10 mL Vial Tray — NDC 0409-4887-34

10 mL Single-dose

Rx only

NDC 0409-4887-34Contains 30 of NDC 0409-4887-32

Sterile Water for Injection, USP

FOR DRUG DILUENT USE

Hospira

PRINCIPAL DISPLAY PANEL — 20 mL Vial Label

20 mL Single-dose

Sterile Water
for Injection, USP

FOR DRUG DILUENT USE

LOT ##-###-AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 20 mL Vial Tray

20 mL Single-dose

Rx only
NDC 0409-4887-20Contains 25 of NDC 0409-4887-23

Sterile Water for Injection, USP

FOR DRUG DILUENT USE

Hospira

PRINCIPAL DISPLAY PANEL — 50 mL Vial Label

50 mL Single-dose

Sterile Water
for Injection, USP

FOR DRUG DILUENT USE

LOT ##-###-AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 50 mL Vial Tray

50 mL Single-dose

Rx only
NDC 0409-4887-50Contains 25 of NDC 0409-4887-24

Sterile Water for Injection, USP

FOR DRUG DILUENT USE

Hospira

STERILE WATER water injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4887 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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-4887-99 25 VIAL, GLASS in 1 CASE contains a VIAL, GLASS (0409-4887-25) 1 NDC:0409-4887-25 100 mL in 1 VIAL, GLASS This package is contained within the CASE (0409-4887-99) 2 NDC:0409-4887-05 25 VIAL, GLASS in 1 TRAY contains a VIAL, GLASS (0409-4887-31) 2 NDC:0409-4887-31 1 mL in 1 VIAL, GLASS This package is contained within the TRAY (0409-4887-05) 3 NDC:0409-4887-10 25 VIAL, PLASTIC in 1 TRAY contains a VIAL, PLASTIC (0409-4887-17) 3 NDC:0409-4887-17 10 mL in 1 VIAL, PLASTIC This package is contained within the TRAY (0409-4887-10) 4 NDC:0409-4887-34 30 VIAL, PLASTIC in 1 TRAY contains a VIAL, PLASTIC (0409-4887-32) 4 NDC:0409-4887-32 10 mL in 1 VIAL, PLASTIC This package is contained within the TRAY (0409-4887-34) 5 NDC:0409-4887-20 25 VIAL, PLASTIC in 1 TRAY contains a VIAL, PLASTIC (0409-4887-23) 5 NDC:0409-4887-23 20 mL in 1 VIAL, PLASTIC This package is contained within the TRAY (0409-4887-20) 6 NDC:0409-4887-50 25 VIAL, PLASTIC in 1 TRAY contains a VIAL, PLASTIC (0409-4887-24) 6 NDC:0409-4887-24 50 mL in 1 VIAL, PLASTIC This package is contained within the TRAY (0409-4887-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018801 06/16/2005

Labeler — Hospira, Inc. (141588017)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		093132819	ANALYSIS (0409-4887), MANUFACTURE (0409-4887), PACK (0409-4887), LABEL (0409-4887)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		827731089	ANALYSIS (0409-4887)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Healthcare India Private Limited		860037912	ANALYSIS (0409-4887), MANUFACTURE (0409-4887), PACK (0409-4887), LABEL (0409-4887)

Revised: 05/2021 Hospira, Inc.