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FDA Drug information

DOXEPIN HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 12 Jan 2025
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Summary of product characteristics


Effective Time

20240703

Version

1

Spl Product Data Elements

DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER opaque white cap opaque white body 1296 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER opaque yellow cap opaque white body 1297 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, PREGELATINIZED CORN TITANIUM DIOXIDE WATER opaque yellow cap opaque yellow body 1298 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 FD&C GREEN NO. 3 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, PREGELATINIZED CORN TITANIUM DIOXIDE WATER opaque green cap opaque green body 1299 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE DOXEPIN ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 FD&C GREEN NO. 3 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, PREGELATINIZED CORN TITANIUM DIOXIDE WATER opaque green cap opaque white body 1300

Application Number

ANDA210700

Brand Name

DOXEPIN HYDROCHLORIDE

Generic Name

DOXEPIN HYDROCHLORIDE

Product Ndc

70771-1385

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1385-1 Doxepin Hydrochloride Capsules USP, 10 mg Rx only 100 Capsules NDC 70771-1386-1 Doxepin Hydrochloride Capsules USP, 25 mg Rx only 100 Capsules NDC 70771-1387-1 Doxepin Hydrochloride Capsules USP, 50 mg Rx only 100 Capsules NDC 70771-1388-1 Doxepin Hydrochloride Capsules USP, 75 mg Rx only 100 Capsules NDC 70771-1389-1 Doxepin Hydrochloride Capsules USP, 100 mg Rx only 100 Capsules 10 mg 25 mg 50 mg 75 mg 100 mg

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