Difluprednate NDC 69097-341

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-341Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0341Add 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
69097-341-35	69097034135	1 BOTTLE in 1 CARTON (69097-341-35) / 5 mL in 1 BOTTLEMarketed from Aug 9, 2021

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: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211776
Marketing start: Aug 9, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 69097-341_825a55a7-ffdf-4fde-bbb2-486cbd16e602SPL ID 825a55a7-ffdf-4fde-bbb2-486cbd16e602SPL set ID 8a7254de-a7a2-476d-9295-c41926267ec9RxCUI 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

N469097034135 followed by a unit qualifier and the quantity

Package 69097-0341-35. 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 10, 2020.

Indications (excerpt from the label)

Difluprednate ophthalmic emulsion is a topical corticosteroid that is 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 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also 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)