Sterile Water
- Product NDC
- 0487-6105
- 11-digit product format
- 004876105
- Labeler code
- 0487
- Product ID
- 0487-6105_39ada97d-53b0-5144-e063-6294a90a91ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sterile Water
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Nephron Pharmaceuticals Corporation
- Application
- ANDA211222
- Marketing category
- ANDA
- Marketing start
- 2021-06-07
- 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 |
|---|
| 0487-6105-01 | Sterile Water | 30 in 1 CARTON | INJECTION | 30 | | 3 |
| 0487-6105-01 | Sterile Water | 5 mL in 1 VIAL, PLASTIC | INJECTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0487-6105 | STERILE WATER INJECTION [NEPHRON PHARMACEUTICALS CORPORATION] | 2 | Current NDC, Legacy NDC, 2 package rows | 20210607_bc04a883-babc-87a6-e053-2995a90a3dfd.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0487-6105-01 | 00487610501 | 30 VIAL, PLASTIC in 1 CARTON (0487-6105-01) / 5 mL in 1 VIAL, PLASTIC | 2021-06-16 | 0000-00-00 | No | No | Current |