FDA Product

DOXEPIN HYDROCHLORIDE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

DOXEPIN HYDROCHLORIDE

FDA Product Code

46708-639

Regulatory Information

NDC Product Code

46708-639

Application Number

ANDA215076

Marketing Category

C73584

Effective Date

January 27, 2023

Territorial Authority

USA

FDA Title

Doxepin Hydrochloride Capsules, USP

Labeling Type

Human Prescription Drug Label

Version Number

2

Company Information

ManufacturerAlembic Pharmaceuticals Limited

DUNS Number

650574663

Active Ingredients

DOXEPIN HYDROCHLORIDE

Quantity: 75 mg in 1 1

Code: 3U9A0FE9N5

Class Code: ACTIM

Inactive Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

Active Moieties

DOXEPIN

Code: 5ASJ6HUZ7D

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