Prescription drug · ANDA
Allopurinol NDC 43063-976
Allopurinol 300 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-976-30 | 43063097630 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-976-30)Marketed from Aug 20, 2019 | |
| 43063-976-90 | 43063097690 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-976-90)Marketed from Apr 29, 2019 |
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
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071450
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 43063-976_587a50f0-12f3-2239-e063-6394a90aa858SPL ID 587a50f0-12f3-2239-e063-6394a90aa858SPL set ID 211e47c6-85b9-43e8-9e07-6cc4b8f708a0RxCUI 197320UNII 63CZ7GJN5IUPC 0343063976906
- 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
N443063097630followed by a unit qualifier and the quantityPackage 43063-0976-30. 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)
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 oxylate 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, oxalate rich foods, refined sugars and i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071450
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 | Northwind Health Company, LLC | 51655-968 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-082 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-157 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-156 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Proficient Rx LP | 71205-377 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-934 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-935 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-975 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-197 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-253 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2775 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Proficient Rx LP | 71205-208 |