DROXIA
- Product NDC
- 80725-830
- 11-digit product format
- 807250830
- Labeler code
- 80725
- Product ID
- 80725-830_3feae4e9-790a-41c7-94df-6baf3ec503ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyurea
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Waylis Therapeutics LLC
- Application
- NDA016295
- Marketing category
- NDA
- Marketing start
- 2025-09-11
- Substance
- HYDROXYUREA
- Active strength
- 300 mg/1
- Pharmacologic classes
- Antimetabolite [EPC], Urea [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DROXIA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYUREA | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X6Q56QN5QC |
| Rxcui | 200342, 200343, 200344, 213282, 213283, 213284 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80725-830-60 | DROXIA | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80725-830-60 | 80725083060 | 60 CAPSULE in 1 BOTTLE (80725-830-60) | 60 capsule | 2025-09-11 | No | No | Current |