Doxepin
These highlights do not include all the information needed to use DOXEPIN TABLETS safely and effectively. See full prescribing information for DOXEPIN TABLETS. DOXEPIN tablets, for oral use Initial U.S. Approval: 1969
Approved
Approval ID
e3eac8e4-224e-4b7b-81d3-071301f914fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Archis Pharma LLC
DUNS: 026836212
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxepin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72819-161
Application NumberANDA202337
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 3 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Doxepin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72819-162
Application NumberANDA202337
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (5)
DOXEPIN HYDROCHLORIDEActive
Quantity: 6 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT