Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

Doxepin Hydrochloride

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

FDA Approval Summary

Company

Contract Pharmacal Corp.

DUNS: 057795122

Effective Date

August 6, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Doxepin(25 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

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Contract Pharmacal Corp.

Labeler

Contract Pharmacal Corp.

Registrant

Contract Pharmacal Corp.

DUNS Number

968335112

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

10267-5060

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 6, 2020

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

10267-5059

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 6, 2020

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

10267-5063

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 6, 2020

Ingredients

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

10267-5061

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 6, 2020

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

10267-5062

Application Number

ANDA213474

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 6, 2020

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy