Sterile Water
- Product NDC
- 63323-178
- 11-digit product format
- 633230178
- Labeler code
- 63323
- Product ID
- 63323-178_d40f0ff2-4abf-4030-b4e1-2b85ad7448a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Water
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA209689
- Marketing category
- ANDA
- Marketing start
- 2017-11-24
- Substance
- WATER
- Active strength
- 1000 mL/1000mL
- 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 | 1000 mL/1000mL |
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 |
|---|
| 63323-178-76 | Sterile Water | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 6 |
| 63323-178-76 | Sterile Water | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-178 | STERILE WATER (WATER) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20221029_b45e9f1d-9c48-4b46-8541-d846b89540df.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-178-76 | 63323017876 | 10 BAG in 1 CASE (63323-178-76) / 1000 mL in 1 BAG | 10 bag | 2017-11-24 | 0000-00-00 | No | No | Current |