Doxepin Hydrochloride (Page 2 of 2)

PRINCIPAL DISPLAY PANEL

DRUG: Doxepin Hydrochloride

GENERIC: Doxepin Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-3327-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: FPP;162

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOXEPIN HYDROCHLORIDE 10mg in 1

INACTIVE INGREDIENT(S):

  • SILICON DIOXIDE
  • AMMONIA
  • MAGNESIUM STEARATE
  • FERROSOFERRIC OXIDE
  • D&C YELLOW NO. 10
  • FD&C YELLOW NO. 6
  • MICROCRYSTALLINE CELLULOSE
  • TITANIUM DIOXIDE
  • POTASSIUM HYDROXIDE
  • SODIUM LAURYL SULFATE
  • GELATIN
  • PROPYLENE GLYCOL
  • SHELLAC
  • STARCH, CORN
Remedy_Label
(click image for full-size original)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-3327(NDC:71921-162)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
AMMONIA
MAGNESIUM STEARATE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
GELATIN
PROPYLENE GLYCOL
SHELLAC
STARCH, CORN
Product Characteristics
Color white (BUFF/BUFF) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code FPP;162
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-3327-0 30 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213474 01/11/2022
Labeler — REMEDYREPACK INC. (829572556)

Revised: 01/2022 REMEDYREPACK INC.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.