Doxepin Hydrochloride
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg
Approved
Approval ID
b787a283-f882-e1f0-e053-2a95a90a8975
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2021
Manufacturers
FDA
Florida Pharmaceutical Products, LLC
DUNS: 084014259
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 Code71921-165
Application NumberANDA213474
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2021
FDA Product Classification
INGREDIENTS (15)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71921-162
Application NumberANDA213474
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2021
FDA Product Classification
INGREDIENTS (15)
DOXEPIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71921-163
Application NumberANDA213474
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2021
FDA Product Classification
INGREDIENTS (15)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71921-164
Application NumberANDA213474
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2021
FDA Product Classification
INGREDIENTS (15)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71921-166
Application NumberANDA213474
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2021
FDA Product Classification
INGREDIENTS (15)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT