boxed warning
Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
Sterile Water
- Product NDC
- 0409-7118
- 11-digit product format
- 004097118
- Labeler code
- 0409
- Product ID
- 0409-7118_bed61dcc-dd36-4ed2-8158-bdfc506f1d3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- WATER
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- NDA019869
- Marketing category
- NDA
- Marketing start
- 2005-08-03
- Marketing end
- 2020-09-01
- Substance
- WATER
- Active strength
- 1 mL/mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0409-7118 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0409-7118 | 0409-7118-07 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019869-001 | STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID / N/A | AP | RLD, RS | 1989-12-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019869-001 | AP |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS FOR DILUTION ONLY. Do not heat over 66°C (150°F). This preparation is solute-free and its entry into the circulation undiluted will cause hemolysis . Absorption of large amounts of Sterile Water for Injection, USP with additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-7118-07 | ML - Milliliter | 0409-7118 | bafdae3c-7ea7-451b-bd41-7d11eefd05ac | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| WATER | ACTIVE INGREDIENT | 059QF0KO0R | STERILE WATER (WATER) INJECTION, SOLUTION [HOSPIRA, INC.] | 14 | |
| WATER | ACTIVE MOIETY | 059QF0KO0R | STERILE WATER (WATER) INJECTION, SOLUTION [HOSPIRA, INC.] | 14 |