Sterile Water
- Product NDC
- 0641-6147
- 11-digit product format
- 006416147
- Labeler code
- 0641
- Product ID
- 0641-6147_081540ac-58cf-437f-ba1b-86d5264ec3dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- WATER
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA206369
- Marketing category
- ANDA
- Marketing start
- 2015-09-03
- 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 |
|---|
| 0641-6147-01 | Sterile Water | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 12 |
| 0641-6147-10 | Sterile Water | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 12 |
| 0641-6147-25 | Sterile Water | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6147 | STERILE WATER (WATER) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20240412_78ef7ad3-451d-43d0-a9b6-5cf0aadca003.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0641-6147-01 | 00641614701 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 0641-6147-10 | 00641614710 | 10 VIAL in 1 CARTON (0641-6147-10) / 10 mL in 1 VIAL (0641-6147-01) | 10 vial | 2015-09-03 | 0000-00-00 | No | No | Current |
| 0641-6147-25 | 00641614725 | 25 VIAL in 1 CARTON (0641-6147-25) / 10 mL in 1 VIAL (0641-6147-01) | 25 vial | 2015-09-03 | 0000-00-00 | No | No | Current |