Prescription drug · NDA AUTHORIZED GENERIC
Allopurinol NDC 16571-884
Allopurinol 200 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-884-01 | 16571088401 | 100 TABLET in 1 BOTTLE (16571-884-01)Marketed from Sep 21, 2023 | |
| 16571-884-09 | 16571088409 | 90 TABLET in 1 BOTTLE (16571-884-09)Marketed from Sep 21, 2023 | |
| 16571-884-10 | 16571088410 | 1000 TABLET in 1 BOTTLE (16571-884-10)Marketed from Sep 21, 2023 | |
| 16571-884-50 | 16571088450 | 500 TABLET in 1 BOTTLE (16571-884-50)Marketed from Sep 21, 2023 |
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)
- Allopurinol
- Generic name (nonproprietary)
- allopurinol
- Active ingredients
- Allopurinol — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 016084
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 16571-884_14a0ad9d-4145-4869-9d8d-747e5d7bfb44SPL ID 14a0ad9d-4145-4869-9d8d-747e5d7bfb44SPL set ID 30ad5ba2-1cef-4933-b104-0597f6a2aaa2RxCUI 197319, 197320, 245422UNII 63CZ7GJN5I
- Pharmacologic class
- Xanthine Oxidase Inhibitor
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
N416571088401followed by a unit qualifier and the quantityPackage 16571-0884-01. 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)
Allopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and inc…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 016084
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 |
|---|---|---|---|---|
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-885 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-883 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Coupler LLC | 67046-1514 |