Prescription drug · ANDA
Allopurinol NDC 82638-113
Allopurinol 300 mg/1 · Tablet · Oral · Harman Finochem Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82638-113-02 | 82638011302 | 100 TABLET in 1 BOTTLE (82638-113-02)Marketed from Oct 6, 2023 | |
| 82638-113-03 | 82638011303 | 500 TABLET in 1 BOTTLE (82638-113-03)Marketed from Oct 6, 2023 | |
| 82638-113-04 | 82638011304 | 1000 TABLET in 1 BOTTLE (82638-113-04)Marketed from Oct 6, 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 — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Harman Finochem Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214443
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 82638-113_2b4201b6-c125-05d2-e063-6294a90a58c1SPL ID 2b4201b6-c125-05d2-e063-6294a90a58c1SPL set ID 0780dc78-d287-d5db-e063-6294a90aa1ddRxCUI 197319, 197320UNII 63CZ7GJN5IUPC 0382638112042, 0382638113049, 0382638112035, 0382638113032, 0382638113025, 0382638112011, 0382638112028
- 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
N482638011302followed by a unit qualifier and the quantityPackage 82638-0113-02. 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)
1. INDICATIONS AND USAGE 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 r…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214443
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 | Harman Finochem Limited | 82638-112 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-710 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Leading Pharma, LLC | 69315-291 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Leading Pharma, LLC | 69315-292 |
| Allopurinol | Allopurinol 200 mg/1 | TabletOral | Leading Pharma, LLC | 69315-409 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3672 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2542 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Coupler LLC | 67046-1639 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-949 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8713 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3803 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8727 |