Prescription drug · ANDA
Hydroxyurea NDC 67046-1619
Hydroxyurea 500 mg/1 · Capsule · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1619-3 | 67046161903 | 30 CAPSULE in 1 BLISTER PACK (67046-1619-3)Marketed from Dec 2, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Hydroxyurea
- Generic name (nonproprietary)
- hydroxyurea
- Active ingredients
- Hydroxyurea — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218021
- Marketing start
- Listing expires
- Other FDA classes
- Urea (Chemical structure)
- Identifiers
- Product ID 67046-1619_44fd4944-cb39-8ec8-e063-6394a90a8588SPL ID 44fd4944-cb39-8ec8-e063-6394a90a8588SPL set ID 44fd5379-5fb0-ff62-e063-6294a90ac792RxCUI 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
N467046161903followed by a unit qualifier and the quantityPackage 67046-1619-03. 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)
Hydroxyurea capsules are 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. Hydroxyurea capsules are 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.
Other NDCs under ANDA 218021
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 |
|---|---|---|---|---|
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Qilu Pharmaceutical Co., Ltd. | 67184-0607 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Somerset Therapeutics, LLC | 70069-820 |