diflunisal NDC 14539-673

NDC codes

FDA NDC Directory

Product NDC (as listed)14539-673Labeler and product segments. Claims need a package NDC.

Product NDC at billing width14539-0673Add 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 NDC	11-digit (billing)	Package
14539-673-01	14539067301	100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01)Marketed from Jan 9, 2019
14539-673-05	14539067305	500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05)Marketed from Jan 9, 2019
14539-673-06	14539067306	60 TABLET, FILM COATED in 1 BOTTLE (14539-673-06)Marketed from Jan 9, 2019

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): diflunisal
Generic name (nonproprietary): diflunisal
Active ingredients: Diflunisal — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202845
Marketing start: Mar 8, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 14539-673_7616a7e4-96d0-4581-9b77-e9292726282bSPL ID 7616a7e4-96d0-4581-9b77-e9292726282bSPL set ID 666f89b4-fd81-420a-a390-eb1cd4014f61RxCUI 197602, 197603, 249400UNII 7C546U4DEN
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

N414539067301 followed by a unit qualifier and the quantity

Package 14539-0673-01. 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 Aug 4, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202845

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

FDA NDC Directory listings under ANDA 202845
Product	Strength	Form · route	Labeler	Product NDC
Dolobiddiflunisal	Diflunisal 250 mg/1	Tablet, Film coatedOral	INA Pharmaceutics Inc	74157-009
Diflunisal	Diflunisal 500 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-456
Dolobiddiflunisal	Diflunisal 375 mg/1	Tablet, Film coatedOral	INA Pharmaceutics Inc	74157-101