FDA.reportPublic FDA data

Trihexyphenidyl Hydrochloride

Product NDC
54738-555
11-digit product format
547380555
Labeler code
54738
Product ID
54738-555_4cf9902d-6772-4e76-ba49-29102fa3d1a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trihexyphenidyl hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Application
ANDA040254
Marketing category
ANDA
Marketing start
1998-12-24
Marketing end
0000-00-00
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54738-555-012020-01-31C16284748780-19d75b9d0-d000-f424-e053-dadaa90a57ceTRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP
54738-555-022020-01-31C16284748780-19d75b9d0-d000-f424-e053-dadaa90a57ceTRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP
54738-555-032020-01-31C16284748780-19d75b9d0-d000-f424-e053-dadaa90a57ceTRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-555-01Trihexyphenidyl Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1004
54738-555-02Trihexyphenidyl Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5004
54738-555-03Trihexyphenidyl Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-555-01EA - Each54738-555d597f4f2-6cad-4447-a646-7bb63061573e12012-07-24
54738-555-03EA - Each54738-555d401f08d-3523-46ef-b506-e3bc2fe7e4a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIHEXYPHENIDYL HYDROCHLORIDEACTIVE INGREDIENTAO61G82577TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]3
TRIHEXYPHENIDYLACTIVE MOIETY6RC5V8B7POTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIHEXYPHENIDYL HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-555TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]4Legacy NDC, 3 package rows20160822_55790126-5489-4c44-947b-5ac9850b9220.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905269trihexyphenidyl HCl 2 MG Oral TabletPSN55790126-5489-4c44-947b-5ac9850b92204
905283trihexyphenidyl HCl 5 MG Oral TabletPSN55790126-5489-4c44-947b-5ac9850b92204
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCD55790126-5489-4c44-947b-5ac9850b92204
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCD55790126-5489-4c44-947b-5ac9850b92204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54738-555-0154738055501100 in 1 BOTTLE, PLASTICHistorical
54738-555-0254738055502500 in 1 BOTTLE, PLASTICHistorical
54738-555-03547380555031000 in 1 BOTTLE, PLASTICHistorical