Sterile Water
- Product NDC
- 65219-497
- 11-digit product format
- 652190497
- Labeler code
- 65219
- Product ID
- 65219-497_7cd9f528-a5da-4541-bb2a-28f3669a6b42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Water
- Dosage form
- INJECTION
- Route
- IRRIGATION
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA216123
- Marketing category
- ANDA
- Marketing start
- 2025-12-19
- 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 |
| Rxcui | 150985 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-497-02 | Sterile Water | 2000 mL in 1 BAG | INJECTION | 2000 | | 4 |
| 65219-497-20 | Sterile Water | 5 in 1 CASE | INJECTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-497 | STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, 2 package rows | 20250402_fd823bef-c14c-4708-a18a-8aaa8470412f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-497-02 | 65219049702 | 2000 mL in 1 BAG | 2000 ml | | | | Historical |
| 65219-497-20 | 65219049720 | 5 BAG in 1 CASE (65219-497-20) / 2000 mL in 1 BAG (65219-497-02) | 5 bag | 2025-12-19 | No | No | Historical |