Home NDC 68682-938 Tolcapone
Product NDC 68682-938
11-digit product format 686820938
Labeler code 68682
Product ID 68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolcapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Oceanside Pharmaceuticals
Application NDA020697
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2004-07-27
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020697-001 TASMAR TOLCAPONE 100MG TABLET / ORAL RLD, RS 1998-01-29 N020697-002 TASMAR TOLCAPONE 200MG TABLET / ORAL 1998-01-29
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 3 · 84 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 N020697-001 TASMAR 100MG TABLET / ORAL RLD, RS 1998-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020697-001 TASMAR 100MG TABLET / ORAL AB RLD, RS 1998-01-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020697-002 TASMAR 200MG TABLET / ORAL 1998-01-29 bb7c543d1eb4…
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 68682-938-90 Tolcapone 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tolcapone ACTIVE INGREDIENT CIF6334OLY TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 Tolcapone ACTIVE MOIETY CIF6334OLY TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 ethylcelluloses INACTIVE INGREDIENT 7Z8S9VYZ4B TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 talc INACTIVE INGREDIENT 7SEV7J4R1U TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3 triacetin INACTIVE INGREDIENT XHX3C3X673 TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-938 TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] 7 Current NDC, Legacy NDC, 1 package rows 20210106_dd367eec-359a-4065-b5c3-7c0107c823fe.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68682-938-90 68682093890 90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90) 2004-07-27 0000-00-00 No No Current