Trihexyphenidyl Hydrochloride

Product NDC
0143-1764
11-digit product format
001431764
Labeler code
0143
Product ID
0143-1764_eb5e1442-b994-478a-8f26-64cbfbd06eb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
West-ward Pharmaceutical Corp
Application
ANDA040337
Marketing category
ANDA
Marketing start
2000-02-16
Marketing end
0000-00-00
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
2 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-1764DDiscontinued by firm2026-08-11
excluded packagepackage0143-17640143-1764-01DDiscontinued by firm2026-08-11
excluded packagepackage0143-17640143-1764-10DDiscontinued by firm2026-08-11
excluded packagepackage0143-17640143-1764-25DDiscontinued by firm2026-08-11

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 · 48 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 packagepackage0143-1764-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1764-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1764-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1764-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1764-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1764-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1764-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1764-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1764-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1764-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1764-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1764-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1764-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1764-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1764-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1764-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1764-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1764-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1764-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1764-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1764-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1764-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1764-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1764-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1764-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1764-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1764-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1764-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1764-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1764-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1764-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1764-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1764-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1764-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1764-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1764-10557ba5c1ecfa…9c80585c8c6e…

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

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
A040337-001TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16
A040337-002TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1764-01EA - Each0143-1764cbfae738-a53e-4145-ac29-2330d6ad18d412012-07-24
0143-1764-10EA - Each0143-176429e46dcc-d84e-4d34-a7c0-1d3a3d53875d12012-07-24