Prescription drug · ANDA
Allopurinol NDC 16729-134
Allopurinol 100 mg/1 · Tablet · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-134-01 | 16729013401 | 100 TABLET in 1 BOTTLE (16729-134-01)Marketed from Apr 29, 2015 | |
| 16729-134-16 | 16729013416 | 500 TABLET in 1 BOTTLE (16729-134-16)Marketed from Jun 14, 2016 |
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
- Labeler
- Accord Healthcare Inc.
- 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 16729-134_40820fd2-3759-d43f-e063-6394a90a7c93SPL ID 40820fd2-3759-d43f-e063-6394a90a7c93SPL set ID 682dd8b8-fc6e-47c5-95b7-82d7ad96b750RxCUI 197319, 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
N416729013401followed by a unit qualifier and the quantityPackage 16729-0134-01. 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 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 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-678 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0112 |
| 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 |