Trihexyphenidyl Hydrochloride
TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
d25fa10c-cc9c-4d8c-9896-4ccc544bbbde
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2013
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0633
Application NumberANDA040254
Product Classification
M
Marketing Category
C73584
G
Generic Name
trihexyphenidyl hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2013
FDA Product Classification
INGREDIENTS (4)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIHEXYPHENIDYL HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: AO61G82577
Classification: ACTIB
trihexyphenidyl hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0634
Application NumberANDA040254
Product Classification
M
Marketing Category
C73584
G
Generic Name
trihexyphenidyl hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2013
FDA Product Classification
INGREDIENTS (4)
TRIHEXYPHENIDYL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: AO61G82577
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/1/2013
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States