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 ID: 70370-3025_62cbc1fe-da3b-436f-ba28-5dca7becb528
• NDC: 70370-3025
• Product Type: Human Prescription Drug
• Proprietary Name: ONGENTYS
• Generic Name: Opicapone
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-24
• Marketing Category: NDA / NDA
• Application Number: NDA212489
• Labeler Name: Neurocrine Biosciences, Inc.
• Substance Name: OPICAPONE
• Active Ingredient Strength: 25 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70370-3025-2

30 CAPSULE in 1 BOTTLE (70370-3025-2)

• Marketing Start Date: 2020-04-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70370-3025-2 [70370302502]

ONGENTYS CAPSULE

• Marketing Category: NDA
• Application Number: NDA212489
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-24

Drug Details

Active Ingredients

Ingredient	Strength
OPICAPONE	25 mg/1

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

NDC	Brand Name	Generic Name
70370-3025	ONGENTYS	opicapone
70370-3050	ONGENTYS	opicapone