Trihexyphenidyl Hydrochloride

Product NDC
53808-0696
11-digit product format
538080696
Labeler code
53808
Product ID
53808-0696_aff840f1-ccb7-4e19-bb26-194f414ff05d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA084364
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0696IInactivated by FDA2026-08-11
excluded packagepackage53808-069653808-0696-1IInactivated by FDA2026-08-11

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53808-0696-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0696-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0696-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0696-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0696-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0696-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0696-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0696-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0696-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0696-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0696-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0696-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0696-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0696-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0696-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0696-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0696-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0696-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0696-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0696-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0696-19bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084364-001TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A084364-001AA

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084364-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAARS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A084364-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084364-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084364-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084364-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084364-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084364-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084364-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084364-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084364-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084364-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084364-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084364-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084364-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084364-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084364-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084364-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084364-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084364-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084364-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084364-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084364-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A084364-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084364-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084364-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084364-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A084364-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084364-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084364-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084364-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084364-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084364-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084364-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084364-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084364-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084364-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084364-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084364-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084364-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084364-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084364-001AA1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca4f09e5-cb3a-0be2-bbd8-d34d4562fedaProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0696-12020-01-31C16284748780-19d75b9d0-22b4-f424-e053-dadaa90a57ceTrihexyphenidyl Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0696-1Trihexyphenidyl Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0696TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_b1468533-a9b8-4377-ae6c-5640e73b9e08.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.3e71b957-9495-4583-8f00-99eac715ff852026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084364
application number: ANDA084364
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.3ed3cdf1-1745-4c6f-bb90-fb7d9471270d2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084364
application number: ANDA084364
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEActavis Pharma, Inc.a44d7803-164d-4a67-9356-581c45de85962024-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084364
application number: ANDA084364

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905283trihexyphenidyl HCl 5 MG Oral TabletPSNb1468533-a9b8-4377-ae6c-5640e73b9e081
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCDb1468533-a9b8-4377-ae6c-5640e73b9e081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0696-15380806960130 in 1 BLISTER PACKHistorical