Sterile Water
- Product NDC
- 0338-0013
- 11-digit product format
- 003380013
- Labeler code
- 0338
- Product ID
- 0338-0013_0d547c0b-bb85-4caa-a4e4-a11a617d2d15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Water
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Company
- Application
- NDA018632
- Marketing category
- NDA
- Marketing start
- 1982-06-30
- Substance
- WATER
- Active strength
- 100 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sterile Water
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| WATER | 100 mL/100mL |
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 |
|---|
| 0338-0013-06 | Sterile Water | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | | 13 |
| 0338-0013-08 | Sterile Water | 3000 mL in 1 BAG | INJECTION, SOLUTION | 3000 | | 13 |
| 0338-0013-29 | Sterile Water | 5000 mL in 1 BAG | INJECTION, SOLUTION | 5000 | | 13 |
| 0338-0013-04 | Sterile Water | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-0013 | STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250529_8bcf5572-49e1-4302-9522-56f57904cb4a.zip |
| 0338-0013 | STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240907_210dc9ab-d6ca-4552-ac19-1be17792d290.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0338-0013-04 | 00338001304 | 1000 mL in 1 BAG (0338-0013-04) | 1000 ml | 1982-06-30 | 0000-00-00 | No | No | Current |
| 0338-0013-06 | 00338001306 | 2000 mL in 1 BAG (0338-0013-06) | 2000 ml | 1982-06-30 | 0000-00-00 | No | No | Current |
| 0338-0013-08 | 00338001308 | 3000 mL in 1 BAG (0338-0013-08) | 3000 ml | 1982-06-30 | 0000-00-00 | No | No | Current |
| 0338-0013-29 | 00338001329 | 5000 mL in 1 BAG (0338-0013-29) | 5000 ml | 1982-06-30 | 0000-00-00 | No | No | Current |