NDC codes

FDA NDC Directory
Product NDC (as listed)15370-170Labeler and product segments. Claims need a package NDC.
Product NDC at billing width15370-0170Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
15370-170-101537001701015370017010100 TABLET in 1 BOTTLE, PLASTIC (15370-170-10)Marketed from May 12, 2022
15370-170-30153700170301537001703030 TABLET in 1 BOTTLE, PLASTIC (15370-170-30)Marketed from Sep 20, 2019
15370-170-60153700170601537001706060 TABLET in 1 BOTTLE, PLASTIC (15370-170-60)Marketed from Feb 28, 2020
15370-170-9915370017099153700170991 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

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

N415370017010 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 203166
ProductStrengthForm · routeLabelerProduct NDC
Nabumetone 1000 mgnabumetoneNabumetone 1000 mg/1Tablet, Film coatedOralLGM PHARMA SOLUTIONS, LLC79739-7078
Nabumetone 500 mgnabumetoneNabumetone 500 mg/1Tablet, Film coatedOralLGM PHARMA SOLUTIONS, LLC79739-7076
Nabumetone 750 mgnabumetoneNabumetone 750 mg/1Tablet, Film coatedOralLGM PHARMA SOLUTIONS, LLC79739-7077

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