Prescription drug · ANDA
Difluprednate NDC 65145-161
Difluprednate .5 mg/mL · Emulsion · Ophthalmic · Caplin Steriles Limited
NDC codes
FDA NDC Directory| 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
- Listing expires
- 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
N465145016101followed by a unit qualifier and the quantityPackage 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
Current FDA label (SPL), effective .
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.
Other NDCs under ANDA 219441
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Difluprednate | Difluprednate .5 mg/mL | EmulsionOphthalmic | Leading Pharma, LLC | 69315-329 |