NDC codes

FDA NDC Directory
Product NDC (as listed)70954-785Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70954-0785Add 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
70954-785-1070954078510100 TABLET, FILM COATED in 1 BOTTLE (70954-785-10)Marketed from Jan 7, 2025
70954-785-2070954078520500 TABLET, FILM COATED in 1 BOTTLE (70954-785-20)Marketed from Jan 7, 2025

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
ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 219118
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 70954-785_36dc4563-e039-496c-9e38-cc41946f1ec5SPL ID 36dc4563-e039-496c-9e38-cc41946f1ec5SPL set ID e87289f4-d4f9-4510-aaa5-51f8f8167658RxCUI 311892, 311893UNII LW0TIW155Z

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

N470954078510 followed by a unit qualifier and the quantity

Package 70954-0785-10. 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 & 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.

Full label on DailyMed (opens in a new tab)

About NDC 70954-785

What is NDC 70954-785?
70954-785 is the product NDC for Nabumetone, Nabumetone 750 mg/1 tablet, film coated, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, 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?
ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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?
59 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nabumetone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NabumetoneNabumetone 500 mg/1Tablet, Film coatedOralANI Pharmaceuticals, Inc.70954-78470954-0784-1070954-0784-20
NabumetoneNabumetone 750 mg/1TabletOralREMEDYREPACK INC.70518-404770518-4047-0070518-4047-0170518-4047-02
NabumetoneNabumetone 500 mg/1TabletOralREMEDYREPACK INC.70518-383570518-3835-0070518-3835-01
NabumetoneNabumetone 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-63060687-0630-21
NabumetoneNabumetone 750 mg/1TabletOralNorthwind Health Company, LLC51655-73351655-0733-52
NabumetoneNabumetone 500 mg/1TabletOraldirect rx72189-18472189-0184-1472189-0184-3072189-0184-60+1 more
NabumetoneNabumetone 500 mg/1TabletOralNorthwind Health Company, LLC51655-44651655-0446-2051655-0446-2551655-0446-52+1 more
NabumetoneNabumetone 500 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-776568788-7765-0168788-7765-0268788-7765-03+3 more
NabumetoneNabumetone 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-39651655-0396-25
NabumetoneNabumetone 750 mg/1TabletOraldirect rx72189-07272189-0072-1472189-0072-3072189-0072-60

All 60 Nabumetone NDCs

Other NDCs under ANDA 219118

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 219118
ProductStrengthForm · routeLabelerProduct NDC
NabumetoneNabumetone 500 mg/1Tablet, Film coatedOralANI Pharmaceuticals, Inc.70954-784

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in