Diflunisal NDC 68382-530

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-530Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0530Add 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
68382-530-01	68382053001	100 TABLET in 1 BOTTLE (68382-530-01)Marketed from Sep 14, 2017
68382-530-05	68382053005	500 TABLET in 1 BOTTLE (68382-530-05)Marketed from Sep 14, 2017
68382-530-06	68382053006	30 TABLET in 1 BOTTLE (68382-530-06)Marketed from Sep 14, 2017
68382-530-10	68382053010	1000 TABLET in 1 BOTTLE (68382-530-10)Marketed from Sep 14, 2017
68382-530-14	68382053014	60 TABLET in 1 BOTTLE (68382-530-14)Marketed from Sep 14, 2017
68382-530-16	68382053016	90 TABLET in 1 BOTTLE (68382-530-16)Marketed from Sep 14, 2017
68382-530-30	68382053030	10 BLISTER PACK in 1 CARTON (68382-530-30) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 14, 2017

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
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203547
Marketing start: Sep 14, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80SPL ID 15c3b31f-e781-4406-a5b4-56c653ecff80SPL set ID 5baf9f35-6b5e-4666-a14a-ac0f9d4e9f76RxCUI 197603UNII 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

N468382053001 followed by a unit qualifier and the quantity

Package 68382-0530-01. 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 5, 2024. 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: 1. Mild to moderate pain 2. Osteoarthritis 3. Rheumatoid arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203547

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

FDA NDC Directory listings under ANDA 203547
Product	Strength	Form · route	Labeler	Product NDC
Diflunisal	Diflunisal 500 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1083