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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

Par Pharmaceutical, Inc.

DUNS: 092733690

Effective Date

October 5, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Doxepin(25 mg in 1 1)

Manufacturing Establishments1

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

Par Formulations Private Limited

Labeler

Par Pharmaceutical, Inc.

DUNS Number

676159161

Products6

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

49884-218

Application Number

ANDA071422

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 5, 2022

Ingredients

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

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

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

49884-219

Application Number

ANDA071422

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 5, 2022

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

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

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

49884-221

Application Number

ANDA071422

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 5, 2022

Ingredients

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

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

49884-220

Application Number

ANDA071422

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 5, 2022

Ingredients

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

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

49884-222

Application Number

ANDA071422

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 5, 2022

Ingredients

Code: 3U9A0FE9N5Class: ACTIMQuantity: 150 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

49884-217

Application Number

ANDA071422

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 5, 2022

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

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