Home NDC 70370-3050-2 ONGENTYS
Product NDC 70370-3050
Requested package NDC 70370-3050-2
11-digit product format 703703050
Labeler code 70370
Product ID 70370-3050_62cbc1fe-da3b-436f-ba28-5dca7becb528
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name opicapone
Dosage form CAPSULE
Route ORAL
Labeler Neurocrine Biosciences, Inc.
Application NDA212489
Marketing category NDA
Marketing start 2020-04-24
Marketing end 0000-00-00
Substance OPICAPONE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 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 8168793 2032-04-07 U-3869 Drug substance, Drug product 2020-05-19 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 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 8168793 2032-04-07 U-3869 Drug substance, Drug product 2020-05-19 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 · 80 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 2026-10-15 13:18:30 2026-09 N212489-001 ONGENTYS 25MG CAPSULE / ORAL RLD 2020-04-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 ONGENTYS 50MG CAPSULE / ORAL RLD, RS 2020-04-24 c2088c7a36db…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…
Observed Orange Book patent history# Patent history page 1 of 22 · 866 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N212489-001 9550759 2026-07-26 U-3870 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 9550759 2026-07-26 U-3871 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 9550759 2026-07-26 U-3872 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 8907099 2027-05-12 Drug substance 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 9745290 2027-10-10 U-3869 Drug product 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 8524746 2029-07-14 U-3869 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 10071085 2030-03-31 Drug product 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 10583130 2030-03-31 U-3869 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 12129247 2032-01-11 U-4038 2024-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 8168793 2032-04-07 U-3869 Drug substance, Drug product 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-001 9630955 2032-12-12 U-3869 Drug substance, Drug product 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 9550759 2026-07-26 U-3870 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 9550759 2026-07-26 U-3871 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 9550759 2026-07-26 U-3872 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 8907099 2027-05-12 Drug substance 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 9745290 2027-10-10 U-3869 Drug product 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 8524746 2029-07-14 U-3869 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 10071085 2030-03-31 Drug product 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 10583130 2030-03-31 U-3869 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 12129247 2032-01-11 U-4038 2024-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 8168793 2032-04-07 U-3869 Drug substance, Drug product 2020-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212489-002 9630955 2032-12-12 U-3869 Drug substance, Drug product 2020-05-19 c2088c7a36db…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…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70370-3050-2 70370305002 30 CAPSULE in 1 BOTTLE (70370-3050-2) 30 capsule 2020-04-24 0000-00-00 No No Current