NDC 70370-3025

ONGENTYS

Opicapone

ONGENTYS is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Neurocrine Biosciences, Inc.. The primary component is Opicapone.

Product ID70370-3025_62cbc1fe-da3b-436f-ba28-5dca7becb528
NDC70370-3025
Product TypeHuman Prescription Drug
Proprietary NameONGENTYS
Generic NameOpicapone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-04-24
Marketing CategoryNDA / NDA
Application NumberNDA212489
Labeler NameNeurocrine Biosciences, Inc.
Substance NameOPICAPONE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70370-3025-2

30 CAPSULE in 1 BOTTLE (70370-3025-2)
Marketing Start Date2020-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70370-3025-2 [70370302502]

ONGENTYS CAPSULE
Marketing CategoryNDA
Application NumberNDA212489
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-24

Drug Details

Active Ingredients

IngredientStrength
OPICAPONE25 mg/1

NDC Crossover Matching brand name "ONGENTYS" or generic name "Opicapone"

NDCBrand NameGeneric Name
70370-3025ONGENTYSopicapone
70370-3050ONGENTYSopicapone

Trademark Results [ONGENTYS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONGENTYS
ONGENTYS
87287421 5784493 Live/Registered
Bial-Portela & Ca., S.A.
2017-01-03
ONGENTYS
ONGENTYS
87287410 not registered Live/Pending
Bial-Portela & Ca., S.A.
2017-01-03
ONGENTYS
ONGENTYS
79233948 not registered Live/Pending
BIAL - PORTELA & CA., S.A.
2018-04-26
ONGENTYS
ONGENTYS
79103307 4228362 Dead/Cancelled
BIAL - PORTELA & CA., S.A.
2011-08-08

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