FDA.reportPublic FDA data

Trihexyphenidyl Hydrochloride

Product NDC
0591-5337
11-digit product format
005915337
Labeler code
0591
Product ID
0591-5337_0b42f7c5-1597-46fd-bc35-5f9286d27877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA084364
Marketing category
ANDA
Marketing start
1987-11-01
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIHEXYPHENIDYL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAO61G82577
Rxcui905269, 905283

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
0591-5337-01Trihexyphenidyl Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10010
0591-5337-10Trihexyphenidyl Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5337-01EA - Each0591-5337b31deceb-bdbf-4688-b7e3-2e61cb63a8f512012-07-24
0591-5337-10EA - Each0591-5337a4c91b59-a4e7-440c-badb-b85b2837980412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIHEXYPHENIDYL HYDROCHLORIDEACTIVE INGREDIENTAO61G82577TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
TRIHEXYPHENIDYLACTIVE MOIETY6RC5V8B7POTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]5
TRIHEXYPHENIDYL HYDROCHLORIDEACTIVE INGREDIENTAO61G82577TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIHEXYPHENIDYLACTIVE MOIETY6RC5V8B7POTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5337TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 2 package rows20250116_a44d7803-164d-4a67-9356-581c45de8596.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905283trihexyphenidyl HCl 5 MG Oral TabletPSN3ed3cdf1-1745-4c6f-bb90-fb7d9471270d15
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCD3ed3cdf1-1745-4c6f-bb90-fb7d9471270d15
905283trihexyphenidyl HCl 5 MG Oral TabletPSN3e71b957-9495-4583-8f00-99eac715ff8512
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCD3e71b957-9495-4583-8f00-99eac715ff8512
905269trihexyphenidyl HCl 2 MG Oral TabletPSNa44d7803-164d-4a67-9356-581c45de859610
905283trihexyphenidyl HCl 5 MG Oral TabletPSNa44d7803-164d-4a67-9356-581c45de859610
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCDa44d7803-164d-4a67-9356-581c45de859610
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCDa44d7803-164d-4a67-9356-581c45de859610
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5337-000059153370033000 TABLET in 1 BAG (0591-5337-00)33000 tablet01-NOV-87Current
0591-5337-0100591533701100 TABLET in 1 BOTTLE, PLASTIC (0591-5337-01) 100 tablet1987-11-010000-00-00NoNoCurrent
0591-5337-10005915337101000 TABLET in 1 BOTTLE, PLASTIC (0591-5337-10) 1000 tablet1987-11-010000-00-00NoNoCurrent
0591-5337-770059153377740008 TABLET in 1 CONTAINER (0591-5337-77)40008 tablet22-JUL-24Current