Sterile Water

Product NDC
0990-7990
11-digit product format
009907990
Labeler code
0990
Product ID
0990-7990_4deb57db-43cf-4a64-ae95-b217e3a4e5f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
water
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA018233
Marketing category
NDA
Marketing start
2019-10-01
Substance
WATER
Active strength
1000 mL/1000mL
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
WATER1000 mL/1000mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii059QF0KO0R

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7990-09Sterile Water1 in 1 POUCHINJECTION, SOLUTION18
0990-7990-09Sterile Water12 in 1 CASEINJECTION, SOLUTION128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7990-09ML - Milliliter0990-79907b17cb77-91e1-48cd-a4e1-79b76b26813612020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7990STERILE WATER (WATER) INJECTION, SOLUTION [ICU MEDICAL INC.]5Current NDC, Legacy NDC, 2 package rows20221203_aab10f03-26ae-4dbc-a481-ef025e48b405.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7990-090099079900912 POUCH in 1 CASE (0990-7990-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG12 pouch2019-10-010000-00-00NoNoCurrent