HYDREA
- Product NDC
- 80725-810
- 11-digit product format
- 807250810
- Labeler code
- 80725
- Product ID
- 80725-810_d30874b9-8639-44b3-a91b-4fcce90ca484
- 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
- 500 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
- HYDREA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYUREA | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X6Q56QN5QC |
| Rxcui | 105602, 197797 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80725-810-10 | HYDREA | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 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 |
|---|
| 80725-810-10 | 80725081010 | 100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10) | 100 capsule | 2025-09-11 | No | No | Historical |