Sterile Water
- Product NDC
- 65219-187
- 11-digit product format
- 652190187
- Labeler code
- 65219
- Product ID
- 65219-187_0a672bdf-163d-4af5-a791-f815de5b309c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- WATER
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA088400
- Marketing category
- ANDA
- Marketing start
- 2022-04-29
- 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 |
|---|
| 65219-187-01 | Sterile Water | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 100 | | 1 |
| 65219-187-10 | Sterile Water | 25 in 1 TRAY | INJECTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-187 | STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220630_f42ac50f-0ec5-4713-a4c8-99d972d90bed.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-187-01 | 65219018701 | 100 mL in 1 VIAL, SINGLE-DOSE | 100 ml | | | | | Historical |
| 65219-187-10 | 65219018710 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-187-10) / 100 mL in 1 VIAL, SINGLE-DOSE (65219-187-01) | | 2022-04-29 | 0000-00-00 | No | No | Current |