Doxepin Hydrochloride

Doxepin Hydrochloride Capsules, USP

Approved

Approval ID

abf4c515-8888-4733-80a0-fd4e1cdb84a2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 29, 2021

Manufacturers

FDA

Appco Pharma LLC

DUNS: 078510186

Products 5

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

Doxepn Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55801-531

Application NumberANDA214908

Product Classification

M

Marketing Category

C73584

G

Generic Name

Doxepn Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateApril 29, 2021

FDA Product Classification

INGREDIENTS (14)

DOXEPIN HYDROCHLORIDEActive

Quantity: 100 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55801-528

Application NumberANDA214908

Product Classification

M

Marketing Category

C73584

G

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateApril 29, 2021

FDA Product Classification

INGREDIENTS (14)

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

DOXEPIN HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55801-527

Application NumberANDA214908

Product Classification

M

Marketing Category

C73584

G

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateApril 29, 2021

FDA Product Classification

INGREDIENTS (13)

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

DOXEPIN HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55801-529

Application NumberANDA214908

Product Classification

M

Marketing Category

C73584

G

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateApril 29, 2021

FDA Product Classification

INGREDIENTS (14)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

DOXEPIN HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

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 Code55801-530

Application NumberANDA214908

Product Classification

M

Marketing Category

C73584

G

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateApril 29, 2021

FDA Product Classification

INGREDIENTS (14)

DOXEPIN HYDROCHLORIDEActive

Quantity: 75 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

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

GELATINInactive

Code: 2G86QN327L

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

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