Prescription drug · ANDA
Allopurinol NDC 71610-678
Allopurinol 100 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-678-30 | 71610067830 | 30 TABLET in 1 BOTTLE (71610-678-30)Marketed from Nov 23, 2022 | |
| 71610-678-60 | 71610067860 | 90 TABLET in 1 BOTTLE (71610-678-60)Marketed from Nov 23, 2022 | |
| 71610-678-80 | 71610067880 | 180 TABLET in 1 BOTTLE (71610-678-80)Marketed from Nov 23, 2022 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203154
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-678_8fc2ce8f-5707-4329-adc7-b1776451e7eaSPL ID 8fc2ce8f-5707-4329-adc7-b1776451e7eaSPL set ID 0155151c-6e84-4f9b-9233-60ffa7483293RxCUI 197319UNII 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
N471610067830followed by a unit qualifier and the quantityPackage 71610-0678-30. 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)
INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets USP reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). Allopurinol tablet USP is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203154
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 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-523 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0206 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Proficient Rx LP | 71205-049 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0467 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0112 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-134 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-135 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-5168 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-6323 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-665 |