Trihexyphenidyl Hydrochloride
TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
b7e4200c-feff-4537-aad1-cf9989fd8c14
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2019
Manufacturers
FDA
Natco Pharma Limited
DUNS: 650224736
Products 2
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 Code63850-0021
Application NumberANDA091630
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trihexyphenidyl Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (4)
TRIHEXYPHENIDYL HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: AO61G82577
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Trihexyphenidyl Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63850-0022
Application NumberANDA091630
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trihexyphenidyl Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (4)
CELLULOSE, MICROCRYSTALLINEInactive
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