Prescription drug · ANDA
Allopurinol NDC 0904-6572
Allopurinol 300 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6572-61 | 0090465726100904657261 | 100 BLISTER PACK in 1 CARTON (0904-6572-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 27, 2003 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075798
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-6572_5ae721f2-1858-4f78-ba84-a7a33f76ac71SPL ID 5ae721f2-1858-4f78-ba84-a7a33f76ac71SPL set ID 8c0f5af5-a453-4641-933f-ccb2625fca39RxCUI 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
N400904657261followed by a unit qualifier and the quantityPackage 00904-6572-61. 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…
Excerpt only. Read the full label for complete information.
About NDC 0904-6572
- What is NDC 0904-6572?
- 0904-6572 is the product NDC for Allopurinol, Allopurinol 300 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 075798
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 | Bryant Ranch Prepack | 63629-2111 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2112 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2113 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1149 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1150 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7981 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8385 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4286 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Par Health USA, LLC | 0603-2115 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Par Health USA, LLC | 0603-2116 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8517 |