Prescription drug · ANDA
Difluprednate (difluprednate ophthalmic) NDC 69238-1380
Difluprednate .5 mg/mL · Emulsion · Ophthalmic · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1380-3 | 69238138003 | 1 BOTTLE in 1 CARTON (69238-1380-3) / 5 mL in 1 BOTTLEMarketed from Nov 18, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 ophthalmic
- Active ingredients
- Difluprednate — .5 mg/mL
- Dosage form
- Emulsion
- Route
- Ophthalmic
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211526
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-1380_61c6afed-db75-4ee3-a7ce-59369192aaf2SPL ID 61c6afed-db75-4ee3-a7ce-59369192aaf2
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
N469238138003followed by a unit qualifier and the quantityPackage 69238-1380-03. 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
The FDA listing for this product does not reference a label (SPL) set.