Doxepin hydrochloride
Doxepin Hydrochloride Capsules, USP
Approved
Approval ID
1513c98c-e7ef-4009-b932-6757048bb86a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2021
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-170
Application NumberANDA212624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (13)
DOXEPIN HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Doxepin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-171
Application NumberANDA212624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (13)
DOXEPIN HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Doxepin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-169
Application NumberANDA212624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (13)
DOXEPIN HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Doxepin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-168
Application NumberANDA212624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (13)
DOXEPIN HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
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 Code27241-167
Application NumberANDA212624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (13)
DOXEPIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT