Protriptyline Hydrochloride
Protriptyline Hydrochloride Tablets, USP
Approved
Approval ID
700abc58-9362-4ef5-9d7a-dd3c4d364d0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Protriptyline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0210
Application NumberANDA078913
Product Classification
M
Marketing Category
C73584
G
Generic Name
Protriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROTRIPTYLINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 44665V00O8
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Protriptyline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0211
Application NumberANDA078913
Product Classification
M
Marketing Category
C73584
G
Generic Name
Protriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PROTRIPTYLINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 44665V00O8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT