Prescription drug · NDA
Ongentys (Opicapone) NDC 64896-402
Opicapone 25 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64896-402-01 | 64896040201 | 30 CAPSULE in 1 BOTTLE (64896-402-01)Marketed from Apr 5, 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)
- Ongentys
- Generic name (nonproprietary)
- opicapone
- Active ingredients
- Opicapone — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 64896
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212489
- Marketing start
- Listing expires
- Other FDA classes
- Catechol O-Methyltransferase Inhibitors (Mechanism)
- Identifiers
- Product ID 64896-402_550f6797-b388-4ceb-885c-ef56f48ae06cSPL ID 550f6797-b388-4ceb-885c-ef56f48ae06cSPL set ID a511a531-112e-43f8-a43f-5334b0efe979RxCUI 2362172, 2362178, 2362180, 2362182UNII Y5929UIJ5NUPC 0364896403018, 0364896402011
- Pharmacologic class
- Catechol-O-Methyltransferase Inhibitor
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N464896040201followed by a unit qualifier and the quantityPackage 64896-0402-01. 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)
ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 64896-402
- What is NDC 64896-402?
- 64896-402 is the product NDC for Ongentys (opicapone), Opicapone 25 mg/1 capsule, 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?
- Ongentys (Opicapone).
- What is the active ingredient?
- Opicapone.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 64896. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ongentys?
- 1 other product NDC are listed under this name. See all Ongentys NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ongentys products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ongentysopicapone | Opicapone 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 64896-403 | 64896-0403-0164896-0403-0264896-0403-03 |
Other NDCs under NDA 212489
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 |
|---|---|---|---|---|
| Ongentysopicapone | Opicapone 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 64896-403 |