Home NDC 0409-0024 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 Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018801-001 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LIQUID / N/A RLD 1982-10-27 N018801-002 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP RLD, RS 1982-10-27 N018801-003 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A AP RLD, RS 1982-10-27 N018801-004 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (50ML) LIQUID / N/A RLD, RS 1982-10-27 N018801-005 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (100ML) LIQUID / N/A RLD, RS 1982-10-27 N018801-006 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LIQUID / N/A RLD, RS 2023-05-02
Therapeutic equivalence codes# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
Additional Listing Data#
Finished product Yes
Brand name base Sterile Water
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WATER 1 mL/mL
Harmonized Identifiers# Field, Values table Field Values Unii 059QF0KO0R
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-0024-01 Sterile Water 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 2 0409-0024-10 Sterile Water 25 in 1 TRAY INJECTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-0024 STERILE WATER (WATER) INJECTION [HOSPIRA, INC.] 1 Current NDC, 2 package rows 20250402_3a6422e1-feee-4095-8883-2b0837039e6e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0409-0024-01 00409002401 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 0409-0024-10 00409002410 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0024-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-0024-01) 2025-03-31 No No Current