Home NDC 50742-193 TOLCAPONE
Product NDC 50742-193
11-digit product format 507420193
Labeler code 50742
Product ID 50742-193_b0eeccbf-775d-4ff7-805c-cc176f965198
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolcapone
Dosage form TABLET
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA208937
Marketing category ANDA
Marketing start 2018-08-21
Substance TOLCAPONE
Active strength 100 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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208937-001 TOLCAPONE TOLCAPONE 100MG TABLET / ORAL 2018-08-07
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 · 42 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 2026-08-18 06:07:40 2026-07 A208937-001 TOLCAPONE 100MG TABLET / ORAL 2018-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208937-001 TOLCAPONE 100MG TABLET / ORAL AB 2018-08-07 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base TOLCAPONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLCAPONE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CIF6334OLY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200220 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 50742-193-90 TOLCAPONE 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-193 TOLCAPONE TABLET [INGENUS PHARMACEUTICALS, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20190911_d94891be-2fef-4e39-8e35-ab7afe93e78e.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 Marketing end Sample Exclude flag Status 50742-193-90 50742019390 90 TABLET in 1 BOTTLE (50742-193-90) 90 tablet 2018-08-21 0000-00-00 No No Current