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 NDC11-digit (billing)PackageCopy
14539-673-011453906730114539067301100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01)Marketed from Jan 9, 2019
14539-673-051453906730514539067305500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05)Marketed from Jan 9, 2019
14539-673-06145390673061453906730660 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202845
Marketing start
Listing expires
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

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 . 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)

About NDC 14539-673

What is NDC 14539-673?
14539-673 is the product NDC for diflunisal, Diflunisal 500 mg/1 tablet, film coated, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
diflunisal.
What is the active ingredient?
Diflunisal.
Who is the labeler?
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 14539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for diflunisal?
4 other product NDCs are listed under this name. See all diflunisal 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 diflunisal NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DiflunisalDiflunisal 500 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-922200093-9222-0100093-9222-0500093-9222-06
DiflunisalDiflunisal 500 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.68382-53068382-0530-0168382-0530-0568382-0530-06+4 more
DiflunisalDiflunisal 500 mg/1TabletOralZydus Lifesciences Limited70771-108370771-1083-0070771-1083-0170771-1083-03+4 more
DiflunisalDiflunisal 500 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-45662135-0456-60

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
ProductStrengthForm · routeLabelerProduct NDC
DiflunisalDiflunisal 500 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-456
DolobiddiflunisalDiflunisal 250 mg/1Tablet, Film coatedOralINA Pharmaceutics Inc74157-009
DolobiddiflunisalDiflunisal 375 mg/1Tablet, Film coatedOralINA Pharmaceutics Inc74157-101

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