Trihexyphenidyl Hydrochloride

Product NDC
0591-5335
11-digit product format
005915335
Labeler code
0591
Product ID
0591-5335_0b42f7c5-1597-46fd-bc35-5f9286d27877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA084363
Marketing category
ANDA
Marketing start
1987-11-01
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 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
0591-5335-01Trihexyphenidyl Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10010
0591-5335-10Trihexyphenidyl Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5335-01EA - Each0591-5335c665d56d-1a07-4137-8e65-13a30908c3f712012-07-24
0591-5335-10EA - Each0591-53355709879d-7db7-4c5e-b017-d62051569bbb12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5335TRIHEXYPHENIDYL 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
905269trihexyphenidyl HCl 2 MG Oral TabletPSN86a65e8a-10f4-4f12-8e65-2edf398daeaa15
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCD86a65e8a-10f4-4f12-8e65-2edf398daeaa15
905269trihexyphenidyl HCl 2 MG Oral TabletPSNe34e1be1-0d59-4625-85a3-babbb7cbd6b811
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCDe34e1be1-0d59-4625-85a3-babbb7cbd6b811
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
905269trihexyphenidyl HCl 2 MG Oral TabletPSNb8ad285a-383a-46bc-90e8-8d58e9a01b942
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCDb8ad285a-383a-46bc-90e8-8d58e9a01b942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5335-0100591533501100 TABLET in 1 BOTTLE, PLASTIC (0591-5335-01) 100 tablet1987-11-010000-00-00NoNoCurrent
0591-5335-10005915335101000 TABLET in 1 BOTTLE, PLASTIC (0591-5335-10) 1000 tablet1987-11-010000-00-00NoNoCurrent