ongentys

Generic: opicapone

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ongentys
Generic Name opicapone
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

opicapone 25 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 64896-402
Product ID 64896-402_550f6797-b388-4ceb-885c-ef56f48ae06c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212489
Listing Expiration 2026-12-31
Marketing Start 2024-04-05

Pharmacologic Class

Established (EPC)
catechol-o-methyltransferase inhibitor [epc]
Mechanism of Action
catechol o-methyltransferase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64896402
Hyphenated Format 64896-402

Supplemental Identifiers

RxCUI
2362172 2362178 2362180 2362182
UPC
0364896403018 0364896402011
UNII
Y5929UIJ5N
NUI
N0000175756 N0000175757

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ongentys (source: ndc)
Generic Name opicapone (source: ndc)
Application Number NDA212489 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (64896-402-01)
source: ndc

Packages (1)

64896-402-01 30 CAPSULE in 1 BOTTLE (64896-402-01)

Ingredients (1)

opicapone (25 mg/1)

Linked Drug Pages (1)

ONGENTYS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "550f6797-b388-4ceb-885c-ef56f48ae06c", "openfda": {"nui": ["N0000175756", "N0000175757"], "upc": ["0364896403018", "0364896402011"], "unii": ["Y5929UIJ5N"], "rxcui": ["2362172", "2362178", "2362180", "2362182"], "spl_set_id": ["a511a531-112e-43f8-a43f-5334b0efe979"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (64896-402-01)", "package_ndc": "64896-402-01", "marketing_start_date": "20240405"}], "brand_name": "ONGENTYS", "product_id": "64896-402_550f6797-b388-4ceb-885c-ef56f48ae06c", "dosage_form": "CAPSULE", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "64896-402", "generic_name": "opicapone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONGENTYS", "active_ingredients": [{"name": "OPICAPONE", "strength": "25 mg/1"}], "application_number": "NDA212489", "marketing_category": "NDA", "marketing_start_date": "20240405", "listing_expiration_date": "20261231"}