Prescription drug · ANDA
Hydroxyurea NDC 49884-724
Hydroxyurea 500 mg/1 · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-724-01 | 49884072401 | 100 CAPSULE in 1 BOTTLE (49884-724-01)Marketed from Feb 24, 1999 |
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)
- Hydroxyurea
- Generic name (nonproprietary)
- hydroxyurea
- Active ingredients
- Hydroxyurea — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075340
- Marketing start
- Listing expires
- Other FDA classes
- Urea (Chemical structure)
- Identifiers
- Product ID 49884-724_4413d36e-3573-4ba9-9baa-c0bbd5e254d5SPL ID 4413d36e-3573-4ba9-9baa-c0bbd5e254d5SPL set ID 9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6RxCUI 197797UNII X6Q56QN5QCUPC 0349884724016
- 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
N449884072401followed by a unit qualifier and the quantityPackage 49884-0724-01. 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.
About NDC 49884-724
- What is NDC 49884-724?
- 49884-724 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydroxyurea.
- What is the active ingredient?
- Hydroxyurea.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydroxyurea?
- 9 other product NDCs are listed under this name. See all Hydroxyurea NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydroxyurea products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1619 | 67046-1619-03 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Somerset Therapeutics, LLC | 70069-820 | 70069-0820-01 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Qilu Pharmaceutical Co., Ltd. | 67184-0607 | 67184-0607-01 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Leading Pharma, LLC | 69315-164 | 69315-0164-01 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-909 | 51407-0909-01 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | AvKARE | 42291-321 | 42291-0321-01 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | American Health Packaging | 68084-284 | 68084-0284-01 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6939 | 00904-6939-61 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0555-0882 | 00555-0882-02 |
Other NDCs under ANDA 075340
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 | Major Pharmaceuticals | 0904-6939 |
| Hydroxyurea | Hydroxyurea 500 mg/1 | CapsuleOral | American Health Packaging | 68084-284 |