FDA.reportPublic FDA data

Trihexyphenidyl Hydrochloride

Product NDC
61748-054
11-digit product format
617480054
Labeler code
61748
Product ID
61748-054_3a17b358-46b6-4e74-9788-ccb8acf9ca8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trihexyphenidyl Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Akorn
Application
ANDA040251
Marketing category
ANDA
Marketing start
2001-03-01
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ca4f09e5-cb3a-0be2-bbd8-d34d4562fedaProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61748-054-16Trihexyphenidyl Hydrochloride473 mL in 1 BOTTLE, PLASTICSYRUP4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61748-054-16ML - Milliliter61748-05445b49142-a3d9-4c34-a318-f7d1fa63ddaa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIHEXYPHENIDYL HYDROCHLORIDEACTIVE INGREDIENTAO61G82577TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
TRIHEXYPHENIDYLACTIVE MOIETY6RC5V8B7POTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
SORBITOLINACTIVE INGREDIENT506T60A25RTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5
WATERINACTIVE INGREDIENT059QF0KO0RTRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61748-054TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [AKORN]9Current NDC, Legacy NDC, 1 package rows20220623_294cd88d-d9e8-4938-b4be-c3adc4a35de0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905273trihexyphenidyl HCl 2 MG in 5 mL Oral SolutionPSN294cd88d-d9e8-4938-b4be-c3adc4a35de09
905273trihexyphenidyl hydrochloride 0.4 MG/ML Oral SolutionSCD294cd88d-d9e8-4938-b4be-c3adc4a35de09
905273trihexyphenidyl HCl 2 MG per 5 ML Oral SolutionSY294cd88d-d9e8-4938-b4be-c3adc4a35de09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61748-054-1661748005416473 mL in 1 BOTTLE, PLASTIC (61748-054-16) 473 ml2001-03-010000-00-00NoNoCurrent