Prescription drug · NDA
Hydrea (Hydroxyurea) NDC 61269-835
Hydroxyurea 500 mg/1 · Capsule · Oral · H2-Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-835-10 | 61269083510 | 100 CAPSULE in 1 BOTTLE (61269-835-10)Marketed from Jun 1, 2009 |
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
- H2-Pharma LLCNDC labeler code 61269
- 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 61269-835_936d1231-1661-44c9-9eb9-0de1d3bf48cbSPL ID 936d1231-1661-44c9-9eb9-0de1d3bf48cbSPL set ID 6053c775-68de-45e4-9af9-33b18fd0e140RxCUI 105602, 197797UNII X6Q56QN5QC
- 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
N461269083510followed by a unit qualifier and the quantityPackage 61269-0835-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 61269-835
- What is NDC 61269-835?
- 61269-835 is the product NDC for Hydrea (hydroxyurea), Hydroxyurea 500 mg/1 capsule, listed with the FDA by H2-Pharma 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?
- H2-Pharma LLC, NDC labeler code 61269. 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 | Waylis Therapeutics LLC | 80725-810 | 80725-0810-10 |
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 | 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 |
| 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 |
| Hydreahydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-810 |