Prescription drug · NDA
Hydrea (Hydroxyurea) NDC 80725-810
Hydroxyurea 500 mg/1 · Capsule · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-810-10 | 80725081010 | 100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)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)
- Hydrea
- Generic name (nonproprietary)
- hydroxyurea
- Active ingredients
- Hydroxyurea — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Waylis Therapeutics LLCNDC labeler code 80725
- 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 80725-810_d30874b9-8639-44b3-a91b-4fcce90ca484SPL ID d30874b9-8639-44b3-a91b-4fcce90ca484SPL set ID 8d41152f-a98a-4abc-afdf-a909012434a0RxCUI 105602, 197797UNII X6Q56QN5QCUPC 0380725810109
- 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
N480725081010followed by a unit qualifier and the quantityPackage 80725-0810-10. 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 .
Indications (excerpt from the label)
HYDREA is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. HYDREA is an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1 ) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 80725-810
- What is NDC 80725-810?
- 80725-810 is the product NDC for Hydrea (hydroxyurea), Hydroxyurea 500 mg/1 capsule, listed with the FDA by Waylis Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrea (Hydroxyurea).
- What is the active ingredient?
- Hydroxyurea.
- Who is the labeler?
- Waylis Therapeutics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrea?
- 1 other product NDC are listed under this name. See all Hydrea NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrea products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydreahydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-835 | 61269-0835-10 |
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 |
|---|---|---|---|---|
| Droxiahydroxyurea | Hydroxyurea 200 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-820 |
| Droxiahydroxyurea | Hydroxyurea 300 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-830 |
| Droxiahydroxyurea | Hydroxyurea 400 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-840 |
| Droxiahydroxyurea | Hydroxyurea 200 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-402 |
| Droxiahydroxyurea | Hydroxyurea 300 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-403 |
| Droxiahydroxyurea | Hydroxyurea 400 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-404 |
| Hydreahydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-835 |