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NDC 70370-3050-05 ONGENTYS 50 mg/1 Details
ONGENTYS 50 mg/1
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.
MedlinePlus Drug Summary
Opicapone is used along with levodopa and carbidopa (Sinemet, Rytary) to treat the end-of-dose 'wearing-off' symptoms of Parkinson's disease. Opicapone is an inhibitor of catechol-O-methyltransferase (COMT). Opicapone helps the levodopa and carbidopa work better by allowing more of it to reach the brain, where it has its effects.
Related Packages: 70370-3050-05Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Opicapone
Product Information
NDC | 70370-3050 |
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Product ID | 70370-3050_d2eba1fb-35ba-40ed-802b-a9c46e36178b |
Associated GPIs | 73153060000120 |
GCN Sequence Number | 079348 |
GCN Sequence Number Description | opicapone CAPSULE 50 MG ORAL |
HIC3 | H6A |
HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
GCN | 45838 |
HICL Sequence Number | 045536 |
HICL Sequence Number Description | OPICAPONE |
Brand/Generic | Brand |
Proprietary Name | ONGENTYS |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | opicapone |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | CAPSULE |
Route | ORAL |
Active Ingredient Strength | 50 |
Active Ingredient Units | mg/1 |
Substance Name | OPICAPONE |
Labeler Name | Neurocrine Biosciences, Inc. |
Pharmaceutical Class | Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA212489 |
Listing Certified Through | 2024-12-31 |
Package
NDC 70370-3050-05 (70370305005)
NDC Package Code | 70370-3050-5 |
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Billing NDC | 70370305005 |
Package | 7 CAPSULE in 1 BOTTLE (70370-3050-5) |
Marketing Start Date | 2020-10-26 |
NDC Exclude Flag | N |
Pricing Information | N/A |