FDA.reportPublic FDA data

Trihexyphenidyl Hydrochloride

Product NDC
69452-241
11-digit product format
694520241
Labeler code
69452
Product ID
69452-241_38f3f3f8-6374-9981-e063-6294a90aa5df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA091630
Marketing category
ANDA
Marketing start
2018-12-15
Marketing end
2026-09-30
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
2 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trihexyphenidyl Hydrochloride

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
69452-241-20Trihexyphenidyl Hydrochloride100 in 1 BOTTLETABLET1003
69452-241-32Trihexyphenidyl Hydrochloride1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-241-20EA - Each69452-2413a27c4e1-00eb-4f3e-a983-6fded66abc2712019-01-24
69452-241-32EA - Each69452-24184d8ad9d-510b-40ef-839d-08ded1777ef912019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-241TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [BIONPHARMA INC.]2Current NDC, Legacy NDC, 2 package rows20250114_4d4d473e-4f84-43e7-bb17-49e8dc1e97fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905269trihexyphenidyl HCl 2 MG Oral TabletPSN4d4d473e-4f84-43e7-bb17-49e8dc1e97fd3
905283trihexyphenidyl HCl 5 MG Oral TabletPSN4d4d473e-4f84-43e7-bb17-49e8dc1e97fd3
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCD4d4d473e-4f84-43e7-bb17-49e8dc1e97fd3
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCD4d4d473e-4f84-43e7-bb17-49e8dc1e97fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-241-2069452024120100 TABLET in 1 BOTTLE (69452-241-20) 100 tablet2018-12-152026-09-30NoNoCurrent
69452-241-32694520241321000 TABLET in 1 BOTTLE (69452-241-32) 1000 tablet2018-12-150000-00-00NoNoCurrent