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FDA Approval

Doxepin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Florida Pharmaceutical Products, LLC

DUNS: 084014259

Effective Date

September 24, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Doxepin(75 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Contract Pharmacal Corp.

DUNS Number

057795122

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Doxepin Hydrochloride

Product Details

NDC Product Code

71921-165

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 24, 2021

Ingredients

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 75 mg in 1 1

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

71921-162

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 24, 2021

Ingredients

Code: 3U9A0FE9N5Class: ACTIMQuantity: 10 mg in 1 1

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

71921-163

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 24, 2021

Ingredients

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 25 mg in 1 1

SHELLACInactive

Code: 46N107B71OClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

71921-164

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 24, 2021

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 50 mg in 1 1

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

71921-166

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 24, 2021

Ingredients

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 100 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

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