Doxepin Hydrochloride (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

DRUG: Doxepin Hydrochloride

GENERIC: Doxepin Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-0386-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 21 mm

IMPRINT: Par;222

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• DOXEPIN HYDROCHLORIDE 150mg in 1

INACTIVE INGREDIENT(S):

• STARCH, CORN
• D&C YELLOW NO. 10
• FD&C BLUE NO. 1
• GELATIN
• MAGNESIUM STEARATE
• SODIUM LAURYL SULFATE
• TITANIUM DIOXIDE

DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0386(NDC:49884-222) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 150 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN MAGNESIUM STEARATE SODIUM LAURYL SULFATE TITANIUM DIOXIDE

Product Characteristics Color white (White Opaque) , blue (Blue Opaque) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code Par;222 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70518-0386-0 30 CAPSULE in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071669 04/03/2017

Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2022 REMEDYREPACK INC.