TRIHEXYPHENIDYL HYDROCHLORIDE

Product NDC
51407-265
11-digit product format
514070265
Labeler code
51407
Product ID
51407-265_064994eb-5baf-6ec2-e063-6394a90a0e78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIHEXYPHENIDYL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply Inc.
Application
ANDA040254
Marketing category
ANDA
Marketing start
1998-12-24
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
2 mg/1
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 packagepackage51407-26551407-265-10DDiscontinued 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 · 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 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
A040254-001TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24
A040254-002TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040254-001AA
A040254-002AA

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 UTC2026-02A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040254-001TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALAA1998-12-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A040254-002TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALAA1998-12-24782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040254-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040254-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040254-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040254-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040254-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040254-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040254-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040254-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040254-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040254-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040254-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040254-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040254-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040254-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040254-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040254-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040254-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040254-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040254-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040254-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040254-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040254-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040254-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040254-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040254-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040254-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040254-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040254-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040254-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040254-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040254-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040254-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040254-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040254-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040254-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040254-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040254-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040254-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040254-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040254-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIHEXYPHENIDYL HYDROCHLORIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AO61G82577Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905269Internal RxNorm lookup
905283Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9040cb3b-13d2-e46d-e053-2a95a90ae9e6Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-265-01TRIHEXYPHENIDYL HYDROCHLORIDE100 in 1 BOTTLETABLET1006
51407-265-10TRIHEXYPHENIDYL HYDROCHLORIDE1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-265-01EA - Each51407-265ff5eeec2-f588-4779-80e8-c8b912c6c14512019-12-10
51407-265-10EA - Each51407-26501e77971-eed2-4b3e-af18-668d855bf3c612019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-265TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.]6Current NDC, Legacy NDC, 2 package rows20230927_9040cb3b-13d2-e46d-e053-2a95a90ae9e6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.c25ea809-5bdf-4917-97f1-610059fbd0b72026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040254
application number: ANDA040254
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.b60ef86c-b8b6-4530-baaf-d4671ce961af2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040254
application number: ANDA040254
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.9040cb3b-13d2-e46d-e053-2a95a90ae9e62023-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040254
application number: ANDA040254
ndc (product): 51407-265
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDENovitium Pharma LLC83608c13-509d-448b-8559-5f5e8a9a0d752019-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040254
application number: ANDA040254

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905269trihexyphenidyl HCl 2 MG Oral TabletPSN9040cb3b-13d2-e46d-e053-2a95a90ae9e66
905283trihexyphenidyl HCl 5 MG Oral TabletPSN9040cb3b-13d2-e46d-e053-2a95a90ae9e66
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCD9040cb3b-13d2-e46d-e053-2a95a90ae9e66
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCD9040cb3b-13d2-e46d-e053-2a95a90ae9e66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-265-0151407026501100 TABLET in 1 BOTTLE (51407-265-01) 100 tablet2019-07-190000-00-00NoNoCurrent
51407-265-10514070265101000 TABLET in 1 BOTTLE (51407-265-10) 1000 tablet2019-07-190000-00-00NoNoCurrent