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 | 6923813800369238138003 | 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 LLCNDC labeler code 69238
- 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.
About NDC 69238-1380
- What is NDC 69238-1380?
- 69238-1380 is the product NDC for Difluprednate (difluprednate ophthalmic), Difluprednate .5 mg/mL emulsion, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Difluprednate (Difluprednate ophthalmic).
- What is the active ingredient?
- Difluprednate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Difluprednate?
- 7 other product NDCs are listed under this name. See all Difluprednate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Difluprednate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Difluprednatedifluprednate ophthalmic | Difluprednate .5 mg/mL | EmulsionOphthalmic | Alembic Pharmaceuticals Limited | 46708-750 | 46708-0750-05 |
| Difluprednatedifluprednate ophthalmic | Difluprednate .5 mg/mL | EmulsionOphthalmic | Alembic Pharmaceuticals Inc. | 62332-750 | 62332-0750-05 |
| Difluprednate | Difluprednate .5 mg/mL | EmulsionOphthalmic | Mylan Pharmaceuticals Inc. | 0378-7518 | 00378-7518-35 |
| Difluprednate | Difluprednate .5 mg/mL | EmulsionOphthalmic | Upsher-Smith Laboratories, LLC | 0832-6054 | 00832-6054-05 |
| Difluprednate | Difluprednate .5 mg/mL | EmulsionOphthalmic | Leading Pharma, LLC | 69315-329 | 69315-0329-05 |
| Difluprednate | Difluprednate .5 mg/mL | EmulsionOphthalmic | Caplin Steriles Limited | 65145-161 | 65145-0161-01 |
| Difluprednate | Difluprednate .5 mg/mL | EmulsionOphthalmic | Cipla USA Inc. | 69097-341 | 69097-0341-35 |