Protriptyline Hydrochloride
Protriptyline Hydrochloride Tablets, USPRx Only
Approved
Approval ID
c6c7c39e-e510-4f4a-bf7a-926f0e075d3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2023
Manufacturers
FDA
Epic Pharma, LLC
DUNS: 827915443
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 Code42806-096
Application NumberANDA202220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Protriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2020
FDA Product Classification
INGREDIENTS (12)
PROTRIPTYLINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 44665V00O8
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, TAPIOCAInactive
Code: 24SC3U704I
Classification: IACT
Protriptyline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-097
Application NumberANDA202220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Protriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2020
FDA Product Classification
INGREDIENTS (12)
PROTRIPTYLINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 44665V00O8
Classification: ACTIB
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT