Doxepin Hydrochloride

Doxepin Hydrochloride capsules, USP Rx only

Approved

Approval ID

14002bad-2577-436d-91ca-ec1b80ab0c97

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 17, 2023

Manufacturers

FDA

PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

DUNS: 080210964

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 Code24658-793

Application NumberANDA210675

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 17, 2023

FDA Product Classification

INGREDIENTS (17)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

DOXEPIN HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-795

Application NumberANDA210675

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 17, 2023

FDA Product Classification

INGREDIENTS (17)

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

DOXEPIN HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-797

Application NumberANDA210675

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 17, 2023

FDA Product Classification

INGREDIENTS (17)

DOXEPIN HYDROCHLORIDEActive

Quantity: 100 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

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 Code24658-796

Application NumberANDA210675

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 17, 2023

FDA Product Classification

INGREDIENTS (17)

DOXEPIN HYDROCHLORIDEActive

Quantity: 75 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

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 Code24658-794

Application NumberANDA210675

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 17, 2023

FDA Product Classification

INGREDIENTS (17)

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

DOXEPIN HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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Doxepin Hydrochloride

Products 5

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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