Doxepin Hydrochloride

Doxepin Hydrochloride capsules

Approved

Approval ID

47bf6f58-627c-4955-a835-ce0556188906

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 1, 2021

Manufacturers

FDA

JUBILANT CADISTA PHARMACEUTICALS INC.

DUNS: 022490515

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 Code59746-702

Application NumberANDA215483

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2021

FDA Product Classification

INGREDIENTS (13)

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

Starch, CornInactive

Code: O8232NY3SJ

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Doxepin HydrochlorideActive

Quantity: 50 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Potassium HydroxideInactive

Code: WZH3C48M4T

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59746-701

Application NumberANDA215483

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2021

FDA Product Classification

INGREDIENTS (13)

Doxepin HydrochlorideActive

Quantity: 25 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Starch, CornInactive

Code: O8232NY3SJ

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

Potassium HydroxideInactive

Code: WZH3C48M4T

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59746-700

Application NumberANDA215483

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2021

FDA Product Classification

INGREDIENTS (12)

Doxepin HydrochlorideActive

Quantity: 10 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Starch, CornInactive

Code: O8232NY3SJ

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Potassium HydroxideInactive

Code: WZH3C48M4T

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59746-704

Application NumberANDA215483

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2021

FDA Product Classification

INGREDIENTS (14)

Doxepin HydrochlorideActive

Quantity: 100 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Starch, CornInactive

Code: O8232NY3SJ

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Potassium HydroxideInactive

Code: WZH3C48M4T

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Doxepin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59746-703

Application NumberANDA215483

Product Classification

Marketing Category

C73584

Generic Name

Doxepin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2021

FDA Product Classification

INGREDIENTS (14)

Doxepin HydrochlorideActive

Quantity: 75 mg in 1 1

Code: 3U9A0FE9N5

Classification: ACTIM

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

Starch, CornInactive

Code: O8232NY3SJ

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Potassium HydroxideInactive

Code: WZH3C48M4T

Classification: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

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Doxepin Hydrochloride

Products 5

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Doxepin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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