Prescription drug · NDA
Allopurinol NDC 0591-5544
Allopurinol 300 mg/1 · Tablet · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-5544-01 | 00591554401 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5544-01)Marketed from Apr 6, 2009 | |
| 0591-5544-05 | 00591554405 | 500 TABLET in 1 BOTTLE, PLASTIC (0591-5544-05)Marketed from Apr 6, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018877
- Marketing start
- Marketing end
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0591-5544_f7e04d88-1d9b-47e6-a9ad-deb08af3c098SPL ID f7e04d88-1d9b-47e6-a9ad-deb08af3c098SPL set ID a80fe56f-8d03-423f-8e2a-7ec8c9e5045bRxCUI 197319, 197320UNII 63CZ7GJN5IUPC 0305915544015, 0305915543018
- 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
N400591554401followed by a unit qualifier and the quantityPackage 00591-5544-01. 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 Tablets are 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 i…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018877
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 | Aphena Pharma Solutions - Tennessee, LLC | 67544-313 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Proficient Rx LP | 63187-240 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1781 |