Prescription drug · ANDA
Allopurinol NDC 80425-0206
Allopurinol 300 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0206-1 | 8042502060180425020601 | 30 TABLET in 1 BOTTLE (80425-0206-1)Marketed from Oct 27, 2023 | |
| 80425-0206-2 | 8042502060280425020602 | 60 TABLET in 1 BOTTLE (80425-0206-2)Marketed from Oct 27, 2023 |
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)
- Allopurinol
- Generic name (nonproprietary)
- allopurinol
- Active ingredients
- Allopurinol — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0206_2a99b834-0c9d-6f97-e063-6394a90a8407SPL ID 2a99b834-0c9d-6f97-e063-6394a90a8407SPL set ID ec09fbcf-6e20-8438-e053-2a95a90a6376RxCUI 197320UNII 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
N480425020601followed by a unit qualifier and the quantityPackage 80425-0206-01. 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)
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 thera…
Excerpt only. Read the full label for complete information.
About NDC 80425-0206
- What is NDC 80425-0206?
- 80425-0206 is the product NDC for Allopurinol, Allopurinol 300 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allopurinol.
- What is the active ingredient?
- Allopurinol.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allopurinol?
- 172 other product NDCs are listed under this name. See all Allopurinol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allopurinol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | AvPAK | 50268-030 | 50268-0030-10 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | AvPAK | 50268-031 | 50268-0031-10 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0282 | 55154-0282-00 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4693 | 70518-4693-00 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Safecor Health, LLC | 48433-003 | 48433-0003-20 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Safecor Health, LLC | 48433-002 | 48433-0002-20 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Coupler LLC | 67046-1658 | 67046-1658-03 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4556 | 70518-4556-00 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-099 | 82868-0099-3082868-0099-90 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-019 | 53401-0019-6053401-0019-80 |
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 | 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 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-523 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-665 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-6323 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Proficient Rx LP | 71205-049 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0112 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0467 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-678 |