FDA.reportPublic FDA data

Trihexyphenidyl Hydrochloride

Product NDC
63850-0022
11-digit product format
638500022
Labeler code
63850
Product ID
63850-0022_2b77cfd6-ad8a-4cbf-a22c-eb69e7a8548c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma Limited
Application
ANDA091630
Marketing category
ANDA
Marketing start
2010-10-07
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
63850-0022-1Trihexyphenidyl Hydrochloride100 in 1 BOTTLETABLET1002
63850-0022-2Trihexyphenidyl Hydrochloride1000 in 1 BOTTLETABLET10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIHEXYPHENIDYL HYDROCHLORIDEACTIVE INGREDIENTAO61G82577TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
TRIHEXYPHENIDYLACTIVE MOIETY6RC5V8B7POTRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63850-0022TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NATCO PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20191101_b7e4200c-feff-4537-aad1-cf9989fd8c14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905269trihexyphenidyl HCl 2 MG Oral TabletPSNb7e4200c-feff-4537-aad1-cf9989fd8c142
905283trihexyphenidyl HCl 5 MG Oral TabletPSNb7e4200c-feff-4537-aad1-cf9989fd8c142
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCDb7e4200c-feff-4537-aad1-cf9989fd8c142
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCDb7e4200c-feff-4537-aad1-cf9989fd8c142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63850-0022-163850002201100 TABLET in 1 BOTTLE (63850-0022-1) 100 tablet2010-10-170000-00-00NoNoCurrent
63850-0022-2638500022021000 TABLET in 1 BOTTLE (63850-0022-2) 1000 tablet2010-10-170000-00-00NoNoCurrent