Prescription drug · ANDA
Hydroxyurea NDC 67184-0607
Hydroxyurea 500 mg/1 · Capsule · Oral · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67184-0607-1 | 67184060701 | 100 CAPSULE in 1 BOTTLE (67184-0607-1)Marketed from Mar 6, 2024 |
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
- 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 67184-0607_a252a0db-b5ce-49d2-b29d-461b34a41479SPL ID a252a0db-b5ce-49d2-b29d-461b34a41479SPL set ID 4cd244d4-bd4a-41c8-b072-c2135787d412RxCUI 197797UNII X6Q56QN5QCUPC 0367184060719
- 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
N467184060701followed by a unit qualifier and the quantityPackage 67184-0607-01. 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 | Somerset Therapeutics, LLC | 70069-820 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1619 |