Sterile Water For Injection, Usp

Drug Facts

Composition & Product

Active Ingredients

Water (1 mL)

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Completed Since 2022-04-22 Until 2021-09-30

Medication Information

Recent Major Changes

NOT FOR DIRECT INJECTION

How Supplied

Sterile Water for Injection, USP NDC 0517-3005-25 5 mL Single Dose Vial Packaged in 25 NDC 0517-3010-25 10 mL Single Dose Vial Packaged in 25 NDC 0517-3020-25 20 mL Single Dose Vial Packaged in 25 NDC 0517-3050-25 50 mL Single Dose Vial Packaged in 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN3005 Rev. 1/09

Description

Rx Only

Section 42229-5

Rx Only

Description:

Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.

Precautions:

Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

How Supplied:

Sterile Water for Injection, USP

NDC 0517-3005-25	5 mL Single Dose Vial	Packaged in 25
NDC 0517-3010-25	10 mL Single Dose Vial	Packaged in 25
NDC 0517-3020-25	20 mL Single Dose Vial	Packaged in 25
NDC 0517-3050-25	50 mL Single Dose Vial	Packaged in 25

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN3005

Rev. 1/09

Serialization Label 5 Ml

Serialization Label 10 Ml

Serialization Label 20 Ml

Principal Display Panel 5 Ml

Contain

NDC 0517-3005-01

STERILE WATER

FOR INJECTION, USP

5 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3005-25

25 x 5 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Principal Display Panel 10 Ml

Container

NDC 0517-3010-01

STERILE WATER

FOR INJECTION, USP

10 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3010-25

25 x 10 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Principal Display Panel 20 Ml

Container

NDC 0517-3020-01

STERILE WATER

FOR INJECTION, USP

20 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3020-25

25 x 20 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 5/18

Structured Label Content

Recent Major Changes (34066-1)

NOT FOR DIRECT INJECTION

Section 42229-5 (42229-5)

Rx Only

Description: (DESCRIPTION:)

Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.

Precautions: (PRECAUTIONS:)

Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

How Supplied: (HOW SUPPLIED:)

Sterile Water for Injection, USP

NDC 0517-3005-25	5 mL Single Dose Vial	Packaged in 25
NDC 0517-3010-25	10 mL Single Dose Vial	Packaged in 25
NDC 0517-3020-25	20 mL Single Dose Vial	Packaged in 25
NDC 0517-3050-25	50 mL Single Dose Vial	Packaged in 25

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN3005

Rev. 1/09

Serialization Label 5 Ml (Serialization Label - 5 mL)

Serialization Label 10 Ml (Serialization Label - 10 mL)

Serialization Label 20 Ml (Serialization Label - 20 mL)

Principal Display Panel 5 Ml (PRINCIPAL DISPLAY PANEL - 5 mL)

Contain

NDC 0517-3005-01

STERILE WATER

FOR INJECTION, USP

5 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3005-25

25 x 5 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Principal Display Panel 10 Ml (PRINCIPAL DISPLAY PANEL - 10 mL)

Container

NDC 0517-3010-01

STERILE WATER

FOR INJECTION, USP

10 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3010-25

25 x 10 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Principal Display Panel 20 Ml (PRINCIPAL DISPLAY PANEL - 20 mL)

Container

NDC 0517-3020-01

STERILE WATER

FOR INJECTION, USP

20 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3020-25

25 x 20 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 5/18

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34066-1": "NOT FOR DIRECT INJECTION", "42229-5": "Rx Only", "DESCRIPTION:": "Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.", "PRECAUTIONS:": "Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.", "HOW SUPPLIED:": "Sterile Water for Injection, USP NDC 0517-3005-25 5 mL Single Dose Vial Packaged in 25 NDC 0517-3010-25 10 mL Single Dose Vial Packaged in 25 NDC 0517-3020-25 20 mL Single Dose Vial Packaged in 25 NDC 0517-3050-25 50 mL Single Dose Vial Packaged in 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN3005 Rev. 1/09", "PRINCIPAL DISPLAY PANEL - 5 mL": "Contain NDC 0517-3005-01 STERILE WATER FOR INJECTION, USP 5 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3005-25 25 x 5 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05", "PRINCIPAL DISPLAY PANEL - 10 mL": "Container NDC 0517-3010-01 STERILE WATER FOR INJECTION, USP 10 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3010-25 25 x 10 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05", "PRINCIPAL DISPLAY PANEL - 20 mL": "Container NDC 0517-3020-01 STERILE WATER FOR INJECTION, USP 20 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3020-25 25 x 20 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 5/18"}

Sterile Water For Injection, Usp

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information