Difluprednate NDC 65145-161

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-161Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0161Add 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
65145-161-01	65145016101	1 BOTTLE in 1 CARTON (65145-161-01) / 5 mL in 1 BOTTLEMarketed from Dec 26, 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): Difluprednate
Generic name (nonproprietary): difluprednate
Active ingredients: Difluprednate — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Caplin Steriles Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219441
Marketing start: Dec 26, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 65145-161_0f9a1987-6a04-4764-94e5-7053997c058bSPL ID 0f9a1987-6a04-4764-94e5-7053997c058bSPL set ID 0f9a1987-6a04-4764-94e5-7053997c058bRxCUI 804544UNII S8A06QG2QEUPC 0365145161017

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

N465145016101 followed by a unit qualifier and the quantity

Package 65145-0161-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 219441

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

FDA NDC Directory listings under ANDA 219441
Product	Strength	Form · route	Labeler	Product NDC
Difluprednate	Difluprednate .5 mg/mL	EmulsionOphthalmic	Leading Pharma, LLC	69315-329