Sterile Water

Product NDC
0409-0024
11-digit product format
004090024
Labeler code
0409
Product ID
0409-0024_7c1a069a-7b47-4a53-a3d6-24c528a3797e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WATER
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
NDA018801
Marketing category
NDA
Marketing start
2025-03-31
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Water
Listing expiration
2027-12-31

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
0409-0024-01Sterile Water10 mL in 1 VIAL, SINGLE-DOSEINJECTION102
0409-0024-10Sterile Water25 in 1 TRAYINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0024-01ML - Milliliter0409-0024cf4230ae-5747-4ef2-9c80-e8c6875298db12025-05-14
0409-0024-10ML - Milliliter0409-00241ec73bd6-2630-4e7a-9753-b763af770c8812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0024STERILE WATER (WATER) INJECTION [HOSPIRA, INC.]1Current NDC, 2 package rows20250402_3a6422e1-feee-4095-8883-2b0837039e6e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-0024-010040900240110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0409-0024-100040900241025 VIAL, SINGLE-DOSE in 1 TRAY (0409-0024-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-0024-01) 2025-03-31NoNoCurrent