Tasmar

Product NDC
0187-0938
11-digit product format
001870938
Labeler code
0187
Product ID
0187-0938_b5c3a96c-28c4-40b3-8b44-e977c4ca2a9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolcapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA020697
Marketing category
NDA
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0187-09380187-0938-07DDiscontinued by firm2026-08-17

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020697-001TASMARTOLCAPONE100MGTABLET / ORALRLD, RS1998-01-29
N020697-002TASMARTOLCAPONE200MGTABLET / ORAL1998-01-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020697-001TASMAR100MGTABLET / ORALRLD, RS1998-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020697-002TASMAR200MGTABLET / ORAL1998-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020697-002TASMAR200MGTABLET / ORAL1998-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020697-002TASMAR200MGTABLET / ORAL1998-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020697-002TASMAR200MGTABLET / ORAL1998-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020697-002TASMAR200MGTABLET / ORAL1998-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020697-002TASMAR200MGTABLET / ORAL1998-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020697-002TASMAR200MGTABLET / ORAL1998-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020697-002TASMAR200MGTABLET / ORAL1998-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020697-002TASMAR200MGTABLET / ORAL1998-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020697-002TASMAR200MGTABLET / ORAL1998-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020697-002TASMAR200MGTABLET / ORAL1998-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020697-002TASMAR200MGTABLET / ORAL1998-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020697-002TASMAR200MGTABLET / ORAL1998-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020697-002TASMAR200MGTABLET / ORAL1998-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020697-002TASMAR200MGTABLET / ORAL1998-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020697-002TASMAR200MGTABLET / ORAL1998-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020697-002TASMAR200MGTABLET / ORAL1998-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020697-002TASMAR200MGTABLET / ORAL1998-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020697-002TASMAR200MGTABLET / ORAL1998-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020697-001TASMAR100MGTABLET / ORALABRLD, RS1998-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020697-002TASMAR200MGTABLET / ORAL1998-01-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020697-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020697-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020697-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020697-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020697-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020697-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020697-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020697-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020697-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020697-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020697-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020697-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020697-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020697-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020697-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020697-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020697-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020697-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020697-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020697-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020697-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020697-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020697-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020697-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020697-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020697-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020697-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020697-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020697-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020697-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020697-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020697-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020697-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020697-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020697-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020697-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020697-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020697-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020697-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020697-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Tasmar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLCAPONE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CIF6334OLYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
153655Internal RxNorm lookup
200220Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0e47a9d-78e7-4523-983a-aa259f221736Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fe4b333-3839-7bde-22f8-71eb964d9c9fProduct name520210204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0938-01Tasmar90 in 1 BOTTLETABLET, FILM COATED9013
0187-0938-07Tasmar21 in 1 BOTTLETABLET, FILM COATED2113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0938-01EA - Each0187-09387c53aa22-5669-4c37-b05f-67044d04396c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolcaponeACTIVE INGREDIENTCIF6334OLYTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
TolcaponeACTIVE MOIETYCIF6334OLYTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
ferric oxide redINACTIVE INGREDIENT1K09F3G675TASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
magnesium stearateINACTIVE INGREDIENT70097M6I30TASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
povidone K30INACTIVE INGREDIENTU725QWY32XTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2TASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
talcINACTIVE INGREDIENT7SEV7J4R1UTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8
triacetinINACTIVE INGREDIENTXHX3C3X673TASMAR (TOLCAPONE) TABLET, FILM COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0938TASMAR (TOLCAPONE) TABLET, FILM COATED [BAUSCH HEALTH US LLC]13Current NDC, Legacy NDC, 2 package rows20210105_a0e47a9d-78e7-4523-983a-aa259f221736.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TasmarTOLCAPONEBausch Health US LLCa0e47a9d-78e7-4523-983a-aa259f2217362020-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020697
application number: NDA020697
ndc (product): 0187-0938
TolcaponeTOLCAPONEOceanside Pharmaceuticalsdd367eec-359a-4065-b5c3-7c0107c823fe2020-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020697
application number: NDA020697

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153655Tasmar 100 MG Oral TabletPSNa0e47a9d-78e7-4523-983a-aa259f22173613
200220tolcapone 100 MG Oral TabletPSNa0e47a9d-78e7-4523-983a-aa259f22173613
153655tolcapone 100 MG Oral Tablet [Tasmar]SBDa0e47a9d-78e7-4523-983a-aa259f22173613
200220tolcapone 100 MG Oral TabletSCDa0e47a9d-78e7-4523-983a-aa259f22173613
153655Tasmar 100 MG Oral TabletSYa0e47a9d-78e7-4523-983a-aa259f22173613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-0938-010018709380190 TABLET, FILM COATED in 1 BOTTLE (0187-0938-01) 2004-07-270000-00-00NoNoCurrent
0187-0938-070018709380721 in 1 BOTTLEHistorical