Doxercalciferol
- Product NDC
- 55150-359
- 11-digit product format
- 551500359
- Labeler code
- 55150
- Product ID
- 55150-359_211361e9-87ad-476a-af8f-8b887c3b6c4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxercalciferol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA213717
- Marketing category
- ANDA
- Marketing start
- 2022-01-24
- Substance
- DOXERCALCIFEROL
- Active strength
- 4 ug/2mL
- Pharmacologic classes
- Ergocalciferols [CS], Vitamin D2 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxercalciferol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXERCALCIFEROL | 4 ug/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3DIZ9LF5Y9 |
| Rxcui | 282609, 1790208, 1790219 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-359-01 | Doxercalciferol | 02 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 02 | | 3 |
| 55150-359-01 | Doxercalciferol | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 55150-359-50 | Doxercalciferol | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-359 | DOXERCALCIFEROL INJECTION, SOLUTION [EUGIA US LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20240222_3376536b-043d-478a-b129-7ce11ec94e3e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-359-01 | 55150035901 | 02 mL in 1 VIAL, MULTI-DOSE | 02 ml | | | | | Historical |
| 55150-359-50 | 55150035950 | 50 CARTON in 1 CARTON (55150-359-50) / 1 VIAL, MULTI-DOSE in 1 CARTON (55150-359-01) / 2 mL in 1 VIAL, MULTI-DOSE | 50 carton | 2022-01-24 | 0000-00-00 | No | No | Current |