Prescription drug · NDA
Droxia (Hydroxyurea) NDC 61269-404
Hydroxyurea 400 mg/1 · Capsule · Oral · H2-Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-404-60 | 6126904046061269040460 | 60 CAPSULE in 1 BOTTLE (61269-404-60)Marketed from Jul 16, 2015 |
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 — 400 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 61269-404_f57fbea0-8124-4877-b7c6-f1b154d8c659SPL ID f57fbea0-8124-4877-b7c6-f1b154d8c659SPL set ID a9494409-3571-4a81-9ad3-15ef7cb636a2RxCUI 200342, 200343, 200344, 213282, 213283, 213284UNII 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
N461269040460followed by a unit qualifier and the quantityPackage 61269-0404-60. 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.
About NDC 61269-404
- What is NDC 61269-404?
- 61269-404 is the product NDC for Droxia (hydroxyurea), Hydroxyurea 400 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?
- Droxia (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 Droxia?
- 5 other product NDCs are listed under this name. See all Droxia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Droxia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Droxiahydroxyurea | Hydroxyurea 200 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-820 | 80725-0820-60 |
| Droxiahydroxyurea | Hydroxyurea 300 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-830 | 80725-0830-60 |
| Droxiahydroxyurea | Hydroxyurea 400 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-840 | 80725-0840-60 |
| Droxiahydroxyurea | Hydroxyurea 200 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-402 | 61269-0402-60 |
| Droxiahydroxyurea | Hydroxyurea 300 mg/1 | CapsuleOral | H2-Pharma LLC | 61269-403 | 61269-0403-60 |
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 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 | H2-Pharma LLC | 61269-835 |
| Hydreahydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-810 |