Doxepin Hydrochloride
Doxepin Hydrochloride Capsules, USP
Approved
Approval ID
2b1f0144-65d8-451f-8054-6be1675f102c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2022
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-089
Application NumberANDA215113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2020
FDA Product Classification
INGREDIENTS (13)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-091
Application NumberANDA215113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2020
FDA Product Classification
INGREDIENTS (13)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-088
Application NumberANDA215113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2020
FDA Product Classification
INGREDIENTS (13)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-092
Application NumberANDA215113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2020
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-090
Application NumberANDA215113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2020
FDA Product Classification
INGREDIENTS (13)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT