Home NDC 64896-402 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212489-001 ONGENTYS OPICAPONE 25MG CAPSULE / ORAL RLD 2020-04-24 N212489-002 ONGENTYS OPICAPONE 50MG CAPSULE / ORAL RLD, RS 2020-04-24
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212489-001 9550759 2026-07-26 U-3870 2020-05-19 N212489-001 9550759 2026-07-26 U-3871 2020-05-19 N212489-001 9550759 2026-07-26 U-3872 2020-05-19 N212489-001 8907099 2027-05-12 Drug substance 2020-05-19 N212489-001 8168793 2027-10-10 U-3869 Drug substance, Drug product 2020-05-19 N212489-001 9745290 2027-10-10 U-3869 Drug product 2020-05-19 N212489-001 8524746 2029-07-14 U-3869 2020-05-19 N212489-001 10071085 2030-03-31 Drug product 2020-05-19 N212489-001 10583130 2030-03-31 U-3869 2020-05-19 N212489-001 12129247 2032-01-11 U-4038 2024-11-26 N212489-001 9630955 2032-12-12 U-3869 Drug substance, Drug product 2020-05-19 N212489-002 9550759 2026-07-26 U-3870 2020-05-19 N212489-002 9550759 2026-07-26 U-3871 2020-05-19 N212489-002 9550759 2026-07-26 U-3872 2020-05-19 N212489-002 8907099 2027-05-12 Drug substance 2020-05-19 N212489-002 8168793 2027-10-10 U-3869 Drug substance, Drug product 2020-05-19 N212489-002 9745290 2027-10-10 U-3869 Drug product 2020-05-19 N212489-002 8524746 2029-07-14 U-3869 2020-05-19 N212489-002 10071085 2030-03-31 Drug product 2020-05-19 N212489-002 10583130 2030-03-31 U-3869 2020-05-19 N212489-002 12129247 2032-01-11 U-4038 2024-11-26 N212489-002 9630955 2032-12-12 U-3869 Drug substance, Drug product 2020-05-19
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 78 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 22 · 844 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N212489-001 9550759 2026-07-26 U-3870 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 9550759 2026-07-26 U-3871 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 9550759 2026-07-26 U-3872 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 8907099 2027-05-12 Drug substance 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 8168793 2027-10-10 U-3869 Drug substance, Drug product 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 9745290 2027-10-10 U-3869 Drug product 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 8524746 2029-07-14 U-3869 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 10071085 2030-03-31 Drug product 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 10583130 2030-03-31 U-3869 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 12129247 2032-01-11 U-4038 2024-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-001 9630955 2032-12-12 U-3869 Drug substance, Drug product 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 9550759 2026-07-26 U-3870 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 9550759 2026-07-26 U-3871 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 9550759 2026-07-26 U-3872 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 8907099 2027-05-12 Drug substance 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 8168793 2027-10-10 U-3869 Drug substance, Drug product 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 9745290 2027-10-10 U-3869 Drug product 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 8524746 2029-07-14 U-3869 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 10071085 2030-03-31 Drug product 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 10583130 2030-03-31 U-3869 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 12129247 2032-01-11 U-4038 2024-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212489-002 9630955 2032-12-12 U-3869 Drug substance, Drug product 2020-05-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212489-001 9550759 2026-07-26 U-3870 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 9550759 2026-07-26 U-3871 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 9550759 2026-07-26 U-3872 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 8907099 2027-05-12 Drug substance 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 8168793 2027-10-10 U-3869 Drug substance, Drug product 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 9745290 2027-10-10 U-3869 Drug product 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 8524746 2029-07-14 U-3869 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 10071085 2030-03-31 Drug product 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 10583130 2030-03-31 U-3869 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 12129247 2032-01-11 U-4038 2024-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-001 9630955 2032-12-12 U-3869 Drug substance, Drug product 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 9550759 2026-07-26 U-3870 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 9550759 2026-07-26 U-3871 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 9550759 2026-07-26 U-3872 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 8907099 2027-05-12 Drug substance 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 8168793 2027-10-10 U-3869 Drug substance, Drug product 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 9745290 2027-10-10 U-3869 Drug product 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212489-002 8524746 2029-07-14 U-3869 2020-05-19 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y5929UIJ5N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2362172 Internal RxNorm lookup 2362178 Internal RxNorm lookup 2362180 Internal RxNorm lookup 2362182 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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