FDA.reportPublic FDA data

STERILE WATER FOR INJECTION, USP (pH 5.0-7.0)

Manufacturer
American Regent, Inc.
Effective date
2022-01-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 20:41:10

Label at a glance#

ProductSterile Water
Active ingredientWATER
Label structure11 sections

Boxed warning

NOT FOR DIRECT INJECTION

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

BOXED WARNING SECTION

NOT FOR DIRECT INJECTION

DESCRIPTION:

DESCRIPTION SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

5 mL container label5 mL container label


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

CartonCarton

PRINCIPAL DISPLAY PANEL - 10 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

10 mL container label10 mL container label

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

Carton Labeling - 10 mLCarton Labeling - 10 mL

PRINCIPAL DISPLAY PANEL - 20 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

20 mL container label20 mL container label

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

Carton Labeling - 20 mLCarton Labeling - 20 mL

Serialization Label - 5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Serialization Label - 5 mL
Serialization Label - 5 mL

Serialization Label - 10 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Serialization Label - 10 mL
Serialization Label - 10 mL

Serialization Label - 20 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Serialization Label - 20 mL
Serialization Label - 20 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-3005-01Sterile Water5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION58
0517-3005-25Sterile Water25 in 1 TRAYINJECTION, SOLUTION258
0517-3010-01Sterile Water10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION108
0517-3010-25Sterile Water25 in 1 TRAYINJECTION, SOLUTION258
0517-3020-01Sterile Water20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION208
0517-3020-25Sterile Water25 in 1 TRAYINJECTION, SOLUTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-3005STERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]8Legacy NDC, 2 package rows20220422_78b35864-4bbc-4759-a5c1-7e4f25e22932.zip
0517-3010STERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]8Current NDC, Legacy NDC, 2 package rows20220422_78b35864-4bbc-4759-a5c1-7e4f25e22932.zip
0517-3020STERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]8Current NDC, Legacy NDC, 2 package rows20220422_78b35864-4bbc-4759-a5c1-7e4f25e22932.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-3005-01ML - Milliliter0517-300515098655-1729-443f-a0c8-04ef0a05124712021-04-08
0517-3005-25ML - Milliliter0517-3005c6878d11-5d41-4c8b-b91b-8e7437809e3912012-07-24
0517-3010-01ML - Milliliter0517-3010eea8a11b-8bdb-4184-bb7c-f02640466f0212022-10-06
0517-3010-25ML - Milliliter0517-30105ba4163c-5e9c-4091-952d-279126ea0c6612012-07-24
0517-3020-01ML - Milliliter0517-3020cd801bab-c0c3-467c-a3a6-9218e370eaac12023-04-07
0517-3020-25ML - Milliliter0517-302054846962-8427-4b11-b2dd-15433cc2f85c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0R2
WATERACTIVE MOIETY059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0517-30050517-3005-01, 0517-3005-25
0517-30100517-3010-01, 0517-3010-25
0517-30200517-3020-01, 0517-3020-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RACTIB
WATER059QF0KO0RACTIB
WATER059QF0KO0RACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
ndc (package): 0517-3020-25
ndc (package): 0517-3005-25
ndc (package): 0517-3010-25
ndc (package): 0517-3005-01
ndc (package): 0517-3020-01
ndc (package): 0517-3010-01
ndc (product): 0517-3010
ndc (product): 0517-3020
ndc (product): 0517-3005
ndc11 (package): 00517300525
ndc11 (package): 00517301001
ndc11 (package): 00517302001
ndc11 (package): 00517300501
ndc11 (package): 00517302025
ndc11 (package): 00517301025
spl id: b885fb92-786e-49bf-aed2-17b430e4743e
spl set id: 78b35864-4bbc-4759-a5c1-7e4f25e22932

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.