Prescription drug · ANDA
Nabumetone NDC 76282-258
Nabumetone 750 mg/1 · Tablet, Film coated · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-258-01 | 76282025801 | 100 TABLET, FILM COATED in 1 BOTTLE (76282-258-01)Marketed from Apr 14, 2015 | |
| 76282-258-05 | 76282025805 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-258-05)Marketed from Apr 14, 2015 |
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)
- Nabumetone
- Generic name (nonproprietary)
- nabumetone
- Active ingredients
- Nabumetone — 750 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078671
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-258_11f0008a-dff5-4fd3-8f48-76d033ea87f5SPL ID 11f0008a-dff5-4fd3-8f48-76d033ea87f5SPL set ID 16e76e29-9315-40c0-b1d6-8d91961063cfRxCUI 311892, 311893UNII LW0TIW155ZUPC 0376282257013, 0376282258010
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N476282025801followed by a unit qualifier and the quantityPackage 76282-0258-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078671
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 |
|---|---|---|---|---|
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-257 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-972 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-630 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0053 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-965 |
| Nabumetone | Nabumetone 750 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-966 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-396 |