FDA.reportPublic FDA data

NDC 0517-3010-01 - Sterile Water

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0517-3010
Requested NDC
0517-3010-01
Package NDCs from labels
0517-3010-01, 0517-3010-25
Manufacturer
American Regent, Inc.
Effective date
2022-01-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
STERILE WATER FOR INJECTION, USP (pH 5.0-7.0)American Regent, Inc.2022-01-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-3010STERILE 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
0517-3010-01ML - Milliliter0517-3010eea8a11b-8bdb-4184-bb7c-f02640466f0212022-10-06
0517-3010-25ML - Milliliter0517-30105ba4163c-5e9c-4091-952d-279126ea0c6612012-07-24

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

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 9 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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