ONGENTYS
- Product NDC
- 64896-402
- 11-digit product format
- 648960402
- Labeler code
- 64896
- Product ID
- 64896-402_550f6797-b388-4ceb-885c-ef56f48ae06c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- opicapone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA212489
- Marketing category
- NDA
- Marketing start
- 2024-04-05
- Substance
- OPICAPONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONGENTYS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OPICAPONE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y5929UIJ5N |
| Rxcui | 2362172, 2362178, 2362180, 2362182 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64896-402-01 | ONGENTYS | 30 in 1 BOTTLE | CAPSULE | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64896-402 | ONGENTYS (OPICAPONE) CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 8 | Current NDC, 1 package rows | 20250330_a511a531-112e-43f8-a43f-5334b0efe979.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64896-402-01 | 64896040201 | 30 CAPSULE in 1 BOTTLE (64896-402-01) | 30 capsule | 2024-04-05 | No | No | Current |