Difluprednate Ophthalmic NDC 0781-6000

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-6000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-6000Add 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
0781-6000-78	00781600078	1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLEMarketed from Sep 15, 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): Difluprednate Ophthalmic
Generic name (nonproprietary): difluprednate ophthalmic
Active ingredients: Difluprednate — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022212
Marketing start: May 15, 2013
Listing expires: Dec 31, 2027
Identifiers: Product ID 0781-6000_a0888296-a4c5-4392-a2a9-98770f6b179aSPL ID a0888296-a4c5-4392-a2a9-98770f6b179aSPL set ID 0f60b857-7898-4a9e-935c-a9ddf0eb9194RxCUI 804544UNII S8A06QG2QEUPC 0307816000782

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

N400781600078 followed by a unit qualifier and the quantity

Package 00781-6000-78. 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)

Difluprednate ophthalmic emulsion 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 Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion 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
Durezoldifluprednate	Difluprednate .5 mg/mL	EmulsionOphthalmic	Sandoz Inc	66758-086