Sterile Water
- Product NDC
- 0143-9339
- 11-digit product format
- 001439339
- Labeler code
- 0143
- Product ID
- 0143-9339_2558c762-cdc9-4135-a83e-8d4c5c9d1afc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sterile Water
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA212735
- Marketing category
- ANDA
- Marketing start
- 2023-05-05
- 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 |
|---|
| 0143-9339-12 | Sterile Water | 12 in 1 CASE | INJECTION, SOLUTION | 12 | | 4 |
| 0143-9339-12 | Sterile Water | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9339 | STERILE WATER INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, 2 package rows | 20230509_b20a28b0-7dfa-42eb-9177-ec256d5a5ef7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0143-9339-12 | 00143933912 | 12 BAG in 1 CASE (0143-9339-12) / 1000 mL in 1 BAG | 12 bag | 2023-05-05 | No | No | Current |