Prescription drug · ANDA
Nabumetone 500 mg (Nabumetone) NDC 79739-7076
Nabumetone 500 mg/1 · Tablet, Film coated · Oral · LGM PHARMA SOLUTIONS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79739-7076-1 | 7973970760179739707601 | 100 TABLET, FILM COATED in 1 BOTTLE (79739-7076-1)Marketed from Sep 4, 2019 | |
| 79739-7076-5 | 7973970760579739707605 | 500 TABLET, FILM COATED in 1 BOTTLE (79739-7076-5)Marketed from Sep 4, 2019 |
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)
- Nabumetone 500 mg
- Generic name (nonproprietary)
- nabumetone
- Active ingredients
- Nabumetone — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- LGM PHARMA SOLUTIONS, LLCNDC labeler code 79739
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203166
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 79739-7076_cf52d275-4853-4576-832a-07630bb644dcSPL ID cf52d275-4853-4576-832a-07630bb644dcSPL set ID ef7c3da8-797f-4ea9-8999-53509785a0f7RxCUI 311892, 311893, 427726UNII LW0TIW155Z
- 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
N479739707601followed by a unit qualifier and the quantityPackage 79739-7076-01. 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 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 are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Excerpt only. Read the full label for complete information.
About NDC 79739-7076
- What is NDC 79739-7076?
- 79739-7076 is the product NDC for Nabumetone 500 mg (nabumetone), Nabumetone 500 mg/1 tablet, film coated, listed with the FDA by LGM PHARMA SOLUTIONS, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nabumetone 500 mg (Nabumetone).
- What is the active ingredient?
- Nabumetone.
- Who is the labeler?
- LGM PHARMA SOLUTIONS, LLC, NDC labeler code 79739. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nabumetone 500 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 203166
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 1000 mgnabumetone | Nabumetone 1000 mg/1 | Tablet, Film coatedOral | LGM PHARMA SOLUTIONS, LLC | 79739-7078 |
| Nabumetone 750 mgnabumetone | Nabumetone 750 mg/1 | Tablet, Film coatedOral | LGM PHARMA SOLUTIONS, LLC | 79739-7077 |
| Relafen Dsnabumetone | Nabumetone 1000 mg/1 | TabletOral | Carwin Pharmaceutical Associates, LLC | 15370-170 |