Prescription drug · ANDA
Relafen Ds (Nabumetone) NDC 15370-170
Nabumetone 1000 mg/1 · Tablet · Oral · Carwin Pharmaceutical Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15370-170-10 | 1537001701015370017010 | 100 TABLET in 1 BOTTLE, PLASTIC (15370-170-10)Marketed from May 12, 2022 | |
| 15370-170-30 | 1537001703015370017030 | 30 TABLET in 1 BOTTLE, PLASTIC (15370-170-30)Marketed from Sep 20, 2019 | |
| 15370-170-60 | 1537001706015370017060 | 60 TABLET in 1 BOTTLE, PLASTIC (15370-170-60)Marketed from Feb 28, 2020 | |
| 15370-170-99 | 1537001709915370017099 | 1 BLISTER PACK in 1 CARTON (15370-170-99) / 2 TABLET in 1 BLISTER PACKMarketed from Feb 28, 2020 · Sample package |
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)
- Relafen Ds
- Generic name (nonproprietary)
- nabumetone
- Active ingredients
- Nabumetone — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Carwin Pharmaceutical Associates, LLCNDC labeler code 15370
- 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 15370-170_48aa3640-1dd2-4693-9b0d-a99595b97a0eSPL ID 48aa3640-1dd2-4693-9b0d-a99595b97a0eSPL set ID a9a0af85-6c43-4a2d-ba75-0be4ca64c931RxCUI 427726, 2200291UNII LW0TIW155ZUPC 0315370170308
- 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
N415370017010followed by a unit qualifier and the quantityPackage 15370-0170-10. 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 15370-170
- What is NDC 15370-170?
- 15370-170 is the product NDC for Relafen Ds (nabumetone), Nabumetone 1000 mg/1 tablet, listed with the FDA by Carwin Pharmaceutical Associates, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Relafen Ds (Nabumetone).
- What is the active ingredient?
- Nabumetone.
- Who is the labeler?
- Carwin Pharmaceutical Associates, LLC, NDC labeler code 15370. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Relafen Ds?
- 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 500 mgnabumetone | Nabumetone 500 mg/1 | Tablet, Film coatedOral | LGM PHARMA SOLUTIONS, LLC | 79739-7076 |
| Nabumetone 750 mgnabumetone | Nabumetone 750 mg/1 | Tablet, Film coatedOral | LGM PHARMA SOLUTIONS, LLC | 79739-7077 |