DOXEPIN HYDROCHLORIDE

Doxepin Hydrochloride Capsules, USP

Approved

Approval ID

e6a4cb10-1928-4abe-8797-404c9ddc37dd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 29, 2023

Manufacturers

FDA

Leading Pharma, LLC

DUNS: 079575060

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 Code69315-161

Application NumberANDA211619

Product Classification

Marketing Category

C73584

Generic Name

DOXEPIN HYDROCHLORIDE

Product Specifications

Route of AdministrationORAL

Effective DateMarch 29, 2023

FDA Product Classification

INGREDIENTS (20)

DOXEPIN HYDROCHLORIDEActive

Quantity: 75 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

DOXEPIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69315-159

Application NumberANDA211619

Product Classification

Marketing Category

C73584

Generic Name

DOXEPIN HYDROCHLORIDE

Product Specifications

Route of AdministrationORAL

Effective DateMarch 29, 2023

FDA Product Classification

INGREDIENTS (20)

DOXEPIN HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

DOXEPIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69315-158

Application NumberANDA211619

Product Classification

Marketing Category

C73584

Generic Name

DOXEPIN HYDROCHLORIDE

Product Specifications

Route of AdministrationORAL

Effective DateMarch 29, 2023

FDA Product Classification

INGREDIENTS (18)

DOXEPIN HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

DOXEPIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69315-160

Application NumberANDA211619

Product Classification

Marketing Category

C73584

Generic Name

DOXEPIN HYDROCHLORIDE

Product Specifications

Route of AdministrationORAL

Effective DateMarch 29, 2023

FDA Product Classification

INGREDIENTS (20)

DOXEPIN HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

DOXEPIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69315-162

Application NumberANDA211619

Product Classification

Marketing Category

C73584

Generic Name

DOXEPIN HYDROCHLORIDE

Product Specifications

Route of AdministrationORAL

Effective DateMarch 29, 2023

FDA Product Classification

INGREDIENTS (20)

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

DOXEPIN HYDROCHLORIDEActive

Quantity: 100 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

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DOXEPIN HYDROCHLORIDE

Products 5

DOXEPIN HYDROCHLORIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

DOXEPIN HYDROCHLORIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

DOXEPIN HYDROCHLORIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

DOXEPIN HYDROCHLORIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

DOXEPIN HYDROCHLORIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

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