Prescription drug · NDA
Droxia (hydroxyurea) NDC 80725-830
Hydroxyurea 300 mg/1 · Capsule · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-830-60 | 80725083060 | 60 CAPSULE in 1 BOTTLE (80725-830-60)Marketed from Sep 11, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Droxia
- Generic name (nonproprietary)
- hydroxyurea
- Active ingredients
- Hydroxyurea — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Waylis Therapeutics LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016295
- Marketing start
- Listing expires
- Other FDA classes
- Urea (Chemical structure)
- Identifiers
- Product ID 80725-830_3feae4e9-790a-41c7-94df-6baf3ec503ffSPL ID 3feae4e9-790a-41c7-94df-6baf3ec503ffSPL set ID 4ad13dc6-a2ab-4308-96b3-7c642c92cc23RxCUI 200342, 200343, 200344, 213282, 213283, 213284UNII X6Q56QN5QCUPC 0380725820603, 0380725830602
- Pharmacologic class
- Antimetabolite
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480725083060followed by a unit qualifier and the quantityPackage 80725-0830-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. DROXIA is an antimetabolite indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 016295
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydreahydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-810 |
| Droxiahydroxyurea | Hydroxyurea 200 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-820 |
| Droxiahydroxyurea | Hydroxyurea 400 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-840 |
| Droxiahydroxyurea | Hydroxyurea 300 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-403 |
| Droxiahydroxyurea | Hydroxyurea 200 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-402 |
| Droxiahydroxyurea | Hydroxyurea 400 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-404 |
| Hydreahydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-835 |