Sterile Water

Product NDC
0264-7385
11-digit product format
002647385
Labeler code
0264
Product ID
0264-7385_ed933e44-2560-495b-879c-99c6a0bf8ba0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Water
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019633
Marketing category
NDA
Marketing start
2014-09-04
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
0264-7385-50Sterile Water2000 mL in 1 CONTAINERINJECTION20006
0264-7385-50Sterile Water4 in 1 CASEINJECTION46
0264-7385-60Sterile Water3000 mL in 1 CONTAINERINJECTION30006
0264-7385-60Sterile Water4 in 1 CASEINJECTION46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-7385-50ML - Milliliter0264-7385a27107d4-7eb2-406e-9bc2-a2577bcfbaaf12015-05-05
0264-7385-60ML - Milliliter0264-73858f4e41b3-7c21-4c34-a263-b364cd18af7512015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0RSTERILE WATER (WATER) INJECTION [B. BRAUN MEDICAL INC.]2
WATERACTIVE MOIETY059QF0KO0RSTERILE WATER (WATER) INJECTION [B. BRAUN MEDICAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-7385STERILE WATER (WATER) INJECTION [B. BRAUN MEDICAL INC.]6Current NDC, Legacy NDC, 4 package rows20210814_8924e52e-8622-4ed6-a061-1908183e0a18.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-7385-50002647385504 CONTAINER in 1 CASE (0264-7385-50) / 2000 mL in 1 CONTAINER4 container2014-09-040000-00-00NoNoCurrent
0264-7385-60002647385604 CONTAINER in 1 CASE (0264-7385-60) / 3000 mL in 1 CONTAINER4 container2014-09-040000-00-00NoNoCurrent