Difluprednate NDC 0378-7518

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7518Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7518Add 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
0378-7518-35	00378751835	1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLEMarketed from Sep 26, 2025

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
Generic name (nonproprietary): difluprednate
Active ingredients: Difluprednate — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212566
Marketing start: Sep 26, 2025
Marketing end: Jun 30, 2027
Identifiers: Product ID 0378-7518_4cd854c9-acfa-4594-9f79-5d33ae0b84c7SPL ID 4cd854c9-acfa-4594-9f79-5d33ae0b84c7SPL set ID 4a3b2649-ee3d-4648-91c8-912a8ba2e73cRxCUI 804544UNII 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

N400378751835 followed by a unit qualifier and the quantity

Package 00378-7518-35. 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 Apr 15, 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)