Sterile Water

Product NDC
0517-3010
11-digit product format
005173010
Labeler code
0517
Product ID
0517-3010_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 Identifiers#

Field, Values table
FieldValues
Unii059QF0KO0R

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 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-3010-010051730100110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0517-3010-250051730102525 VIAL, SINGLE-DOSE in 1 TRAY (0517-3010-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-3010-01) 2022-04-220000-00-00NoNoCurrent