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TRIHEXYPHENIDYL HYDROCHLORIDE

Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only

Approved
Approval ID

7122d191-4972-4baf-a171-b7efd99d02ff

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-5205
Application NumberANDA040254
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRIHEXYPHENIDYL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2019
FDA Product Classification

INGREDIENTS (4)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRIHEXYPHENIDYL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: AO61G82577
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 1/28/2019

DESCRIPTION

Trihexyphenidyl hydrochloride Tablets, USP is a synthetic antispasmodic drug available in the following forms: Tablets, 2 mg and 5 mg. It is designated chemically 1-Piperidinepropanol,α-cyclohexyl-α-phenyl-, hydrochloride. The structural formula is represented below:

structure

Trihexyphenidyl Hydrochloride Tablets, USP 2 mg and 5 mg contain the following inactive ingredients: Microcrystalline cellulose, magnesium stearate and sodium starch glycolate.

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TRIHEXYPHENIDYL HYDROCHLORIDE - FDA Drug Approval Details