FDA.reportPublic FDA data

Sterile Water

Product NDC
0338-0004
11-digit product format
003380004
Labeler code
0338
Product ID
0338-0004_97390588-b679-4caa-b7f3-3d2e11074d0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Water
Dosage form
IRRIGANT
Route
IRRIGATION
Labeler
Baxter Healthcare Corporation
Application
NDA017428
Marketing category
NDA
Marketing start
1974-12-31
Substance
WATER
Active strength
100 mL/100mL
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
WATER100 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii059QF0KO0R
Rxcui150985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0004-02Sterile Water24 in 1 CARTONIRRIGANT2416
0338-0004-02Sterile Water250 mL in 1 BOTTLE, PLASTICIRRIGANT25016
0338-0004-03Sterile Water18 in 1 CARTONIRRIGANT1816
0338-0004-03Sterile Water500 mL in 1 BOTTLE, PLASTICIRRIGANT50016
0338-0004-04Sterile Water1000 mL in 1 BOTTLE, PLASTICIRRIGANT100016
0338-0004-04Sterile Water12 in 1 CARTONIRRIGANT1216
0338-0004-05Sterile Water1500 mL in 1 BOTTLE, PLASTICIRRIGANT150016
0338-0004-05Sterile Water9 in 1 CARTONIRRIGANT916

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0004-02ML - Milliliter0338-000497a1a26a-8bbb-4cad-8455-fae5ff1747e312012-07-24
0338-0004-03ML - Milliliter0338-0004b8f88bb5-7ea5-4093-8e7b-89e5f3af2f7b12013-02-13
0338-0004-04ML - Milliliter0338-000424fbca35-41e2-431e-97e2-19f0ca2b522c12012-07-24
0338-0004-05ML - Milliliter0338-00041ed29dd4-04b1-43e5-874f-62b19ba6b64212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0RSTERILE WATER (WATER) IRRIGANT [BAXTER HEALTHCARE CORPORATION]4
WATERACTIVE MOIETY059QF0KO0RSTERILE WATER (WATER) IRRIGANT [BAXTER HEALTHCARE CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0004STERILE WATER (WATER) IRRIGANT [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 8 package rows20250522_ef3e79c5-3f58-4b36-a296-64b7d9a651c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
150985water 100 % Irrigation SolutionPSNef3e79c5-3f58-4b36-a296-64b7d9a651c116
150985water 1000 MG/ML Irrigation SolutionSCDef3e79c5-3f58-4b36-a296-64b7d9a651c116
150985water 100 % Irrigation SolutionSYef3e79c5-3f58-4b36-a296-64b7d9a651c116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0338-0004-020033800040224 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTIC1974-12-310000-00-00NoNoCurrent
0338-0004-030033800040318 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTIC1974-12-310000-00-00NoNoCurrent
0338-0004-040033800040412 BOTTLE, PLASTIC in 1 CARTON (0338-0004-04) / 1000 mL in 1 BOTTLE, PLASTIC1974-12-310000-00-00NoNoCurrent
0338-0004-05003380004059 BOTTLE, PLASTIC in 1 CARTON (0338-0004-05) > 1500 mL in 1 BOTTLE, PLASTIC1974-12-312022-10-31NoNoCurrent