FDA.reportPublic FDA data

Sterile Water

Product NDC
0517-3020
11-digit product format
005173020
Labeler code
0517
Product ID
0517-3020_b885fb92-786e-49bf-aed2-17b430e4743e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Water
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-04-22
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Water
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
78b35864-4bbc-4759-a5c1-7e4f25e22932Available on FDA.report

DailyMed Package Descriptions#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0RSTERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]2
WATERACTIVE MOIETY059QF0KO0RSTERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]2

DailyMed Dashboard NDC Coverage#

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

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 (product): 0517-3020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-3020-010051730200120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0517-3020-250051730202525 VIAL, SINGLE-DOSE in 1 TRAY (0517-3020-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0517-3020-01) 2022-04-220000-00-00NoNoCurrent