Sterile Water
- Product NDC
- 0404-9959
- 11-digit product format
- 004049959
- Labeler code
- 0404
- Product ID
- 0404-9959_2d56a116-dc8f-4835-b3f4-78128cb907aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Water
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Application
- NDA018801
- Marketing category
- NDA
- Marketing start
- 2022-01-12
- 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 |
|---|
| 0404-9959-10 | Sterile Water | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 6 |
| 0404-9959-10 | Sterile Water | 1 in 1 BAG | INJECTION | 1 | | 6 |
| 0404-9959-20 | Sterile Water | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 6 |
| 0404-9959-20 | Sterile Water | 1 in 1 BAG | INJECTION | 1 | | 6 |
| 0404-9959-50 | Sterile Water | 1 in 1 BAG | INJECTION | 1 | | 6 |
| 0404-9959-50 | Sterile Water | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9959 | STERILE WATER (WATER) INJECTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240531_88403fcf-a276-42c0-88b6-bd84a720b564.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9959-10 | 00404995910 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-01-12 | 2027-08-31 | No | No | Current |
| 0404-9959-20 | 00404995920 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-20) / 20 mL in 1 VIAL, SINGLE-DOSE | 2022-01-12 | 0000-00-00 | No | No | Current |
| 0404-9959-50 | 00404995950 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-50) / 50 mL in 1 VIAL, SINGLE-DOSE | 2022-01-12 | 0000-00-00 | No | No | Current |