Prescription drug · ANDA
Allopurinol NDC 70771-1126
Allopurinol 100 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1126-0 | 70771112600 | 1000 TABLET in 1 BOTTLE (70771-1126-0)Marketed from Feb 8, 2018 | |
| 70771-1126-1 | 70771112601 | 100 TABLET in 1 BOTTLE (70771-1126-1)Marketed from Feb 8, 2018 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210117
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1126_183fab96-5c7b-4fcc-a475-5d1832bbf9c6SPL ID 183fab96-5c7b-4fcc-a475-5d1832bbf9c6SPL set ID 9232f484-a5f6-4c63-b7f4-b510d2827159RxCUI 197319, 197320, 245422UNII 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
N470771112600followed by a unit qualifier and the quantityPackage 70771-1126-00. 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 tablet is 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 inc…
Excerpt only. Read the full label for complete information.
About NDC 70771-1126
- What is NDC 70771-1126?
- 70771-1126 is the product NDC for Allopurinol, Allopurinol 100 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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?
- 167 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 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 100 mg/1 | TabletOral | Safecor Health, LLC | 48433-002 | 48433-0002-20 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Safecor Health, LLC | 48433-003 | 48433-0003-20 |
| 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 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-025 | 53401-0025-60 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | XLCare Pharmaceuticals Inc. | 72865-303 | 72865-0303-0172865-0303-0572865-0303-10+1 more |
Other NDCs under ANDA 210117
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 | Major Pharmaceuticals | 0904-7041 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2338 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1209 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1210 |
| Allopurinol | Allopurinol 200 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-2009 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1127 |
| Allopurinol | Allopurinol 200 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1907 |