Sterile Water
- Product NDC
- 0404-9781
- 11-digit product format
- 004049781
- Labeler code
- 0404
- Product ID
- 0404-9781_d2b21939-b988-410f-830c-e36a4b7f447f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- water injection
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA206369
- Marketing category
- ANDA
- Marketing start
- 2025-08-28
- Substance
- WATER
- Active strength
- 1 mL/mL
- 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| 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 |
|---|
| 0404-9781-10 | Sterile Water | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 1 |
| 0404-9781-10 | Sterile Water | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9781-10 | 00404978110 | 1 VIAL in 1 BAG (0404-9781-10) / 10 mL in 1 VIAL | 1 vial | 2025-08-28 | No | No | Current |