Durezol (difluprednate) NDC 66758-086

NDC codes

FDA NDC Directory

Product NDC (as listed)66758-086Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66758-0086Add 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	Copy
66758-086-75	66758008675	1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLEMarketed from Dec 6, 2024

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): Durezol
Generic name (nonproprietary): difluprednate
Active ingredients: Difluprednate — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022212
Marketing start: Jan 25, 2011
Listing expires: Dec 31, 2027
Identifiers: Product ID 66758-086_c55f3f94-e85c-4d86-9168-6b548bfd1d86SPL ID c55f3f94-e85c-4d86-9168-6b548bfd1d86SPL set ID ea520a27-f569-4b31-8bad-a25ad54b2caaRxCUI 804544, 804547UNII S8A06QG2QE

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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N466758008675 followed by a unit qualifier and the quantity

Package 66758-0086-75. 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 18, 2026.

Indications (excerpt from the label)

DUREZOL ® is a corticosteroid indicated for: • The treatment of inflammation and pain associated with ocular surgery. ( 1.1 ) • The treatment of endogenous anterior uveitis. ( 1.2 ) 1.1 Ocular Surgery DUREZOL is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis DUREZOL is indicated for the treatment of endogenous anterior uveitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022212

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

FDA NDC Directory listings under NDA 022212
Product	Strength	Form · route	Labeler	Product NDC
Difluprednate Ophthalmic	Difluprednate .5 mg/mL	EmulsionOphthalmic	Sandoz Inc	0781-6000