NDC codes

FDA NDC Directory
Product NDC (as listed)0093-9222Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-9222Add 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
0093-9222-010009392220100093922201100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01)Marketed from Jun 30, 2021
0093-9222-050009392220500093922205500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05)Marketed from Aug 25, 2022
0093-9222-06000939222060009392220660 TABLET, FILM COATED in 1 BOTTLE (0093-9222-06)Marketed from Jun 30, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 073673
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0093-9222_673f00c6-1759-47a6-a098-fd61baf13d1eSPL ID 673f00c6-1759-47a6-a098-fd61baf13d1eSPL set ID 7a78bb38-14d8-4a90-b883-482d4cebf716RxCUI 197603UNII 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

N400093922201 followed by a unit qualifier and the quantity

Package 00093-9222-01. 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 0093-9222

What is NDC 0093-9222?
0093-9222 is the product NDC for Diflunisal, Diflunisal 500 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, 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?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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/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 coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.14539-67314539-0673-0114539-0673-0514539-0673-06
DiflunisalDiflunisal 500 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-45662135-0456-60

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