FDA.reportPublic FDA data

Trihexyphenidyl Hydrochloride

Product NDC
0121-0658
11-digit product format
001210658
Labeler code
0121
Product ID
0121-0658_e3815d2f-f3ee-4cd6-8a2d-518c74787152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA040177
Marketing category
ANDA
Marketing start
1997-05-15
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
2 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAO61G82577
Rxcui905273

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
0121-0658-16Trihexyphenidyl Hydrochloride473 mL in 1 BOTTLESOLUTION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0658-16ML - Milliliter0121-0658a60e8e66-e78d-44d1-b4ad-3486d25c865512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Trihexyphenidyl HydrochlorideACTIVE INGREDIENTAO61G82577TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
TrihexyphenidylACTIVE MOIETY6RC5V8B7POTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RTRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0658TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 1 package rows20241121_9036c9f0-6d2d-4d0f-a20e-e36f9be228f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905273trihexyphenidyl HCl 2 MG in 5 mL Oral SolutionPSN9036c9f0-6d2d-4d0f-a20e-e36f9be228f78
905273trihexyphenidyl hydrochloride 0.4 MG/ML Oral SolutionSCD9036c9f0-6d2d-4d0f-a20e-e36f9be228f78
905273trihexyphenidyl HCl 2 MG per 5 ML Oral SolutionSY9036c9f0-6d2d-4d0f-a20e-e36f9be228f78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0658-1600121065816473 mL in 1 BOTTLE (0121-0658-16) 473 ml1997-05-150000-00-00NoNoCurrent