STERILE WATER

Product NDC
0404-9971
11-digit product format
004049971
Labeler code
0404
Product ID
0404-9971_89dfebe4-a611-4fbb-9e79-b4b2ac6311cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WATER
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Henry Schein, Inc.
Application
NDA018801
Marketing category
NDA
Marketing start
2022-01-10
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
0404-9971-00STERILE WATER100 mL in 1 VIAL, GLASSINJECTION1007
0404-9971-00STERILE WATER1 in 1 BAGINJECTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9971STERILE WATER (WATER) INJECTION [HENRY SCHEIN, INC.]6Current NDC, Legacy NDC, 2 package rows20240823_f4087143-9868-4308-b96c-43657ee8ec28.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9971-00004049971001 VIAL, GLASS in 1 BAG (0404-9971-00) / 100 mL in 1 VIAL, GLASS2022-01-100000-00-00NoNoCurrent