Prescription drug · ANDA
Nabumetone NDC 80425-0053
Nabumetone 500 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0053-1 | 8042500530180425005301 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0053-1)Marketed from Mar 6, 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
- Generic name (nonproprietary)
- nabumetone
- Active ingredients
- Nabumetone — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- 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 80425-0053_2a98d9c1-b76e-40b1-e063-6294a90a20e4SPL ID 2a98d9c1-b76e-40b1-e063-6294a90a20e4SPL set ID af9969df-ce14-c0bc-e053-2995a90a3f59RxCUI 311892UNII 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
N480425005301followed by a unit qualifier and the quantityPackage 80425-0053-01. 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 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.
About NDC 80425-0053
- What is NDC 80425-0053?
- 80425-0053 is the product NDC for Nabumetone, Nabumetone 500 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nabumetone.
- What is the active ingredient?
- Nabumetone.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?
- 57 other product NDCs are listed under this name. See all Nabumetone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nabumetone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-784 | 70954-0784-1070954-0784-20 |
| Nabumetone | Nabumetone 750 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-785 | 70954-0785-1070954-0785-20 |
| Nabumetone | Nabumetone 750 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4047 | 70518-4047-0070518-4047-0170518-4047-02 |
| Nabumetone | Nabumetone 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3835 | 70518-3835-0070518-3835-01 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-630 | 60687-0630-21 |
| Nabumetone | Nabumetone 750 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-733 | 51655-0733-52 |
| Nabumetone | Nabumetone 500 mg/1 | TabletOral | direct rx | 72189-184 | 72189-0184-1472189-0184-3072189-0184-60+1 more |
| Nabumetone | Nabumetone 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-446 | 51655-0446-2051655-0446-2551655-0446-52+1 more |
| Nabumetone | Nabumetone 500 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7765 | 68788-7765-0168788-7765-0268788-7765-03+3 more |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-396 | 51655-0396-25 |
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 | PD-Rx Pharmaceuticals, Inc. | 43063-972 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-396 |
| Nabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-630 |
| 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 | Exelan Pharmaceuticals Inc. | 76282-257 |
| Nabumetone | Nabumetone 750 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-258 |