Prescription Drug Information: Doxepin Hydrochloride (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 25 mg

Doxepin HCl
Capsules, USP
25 mg*

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

55289370 Label
(click image for full-size original)
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-370(NDC:0378-3125)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white (Ivory opaque) , white (White opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code MYLAN;3125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55289-370-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:55289-370-90 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070791 05/13/1986
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (55289-370)

Revised: 05/2022 PD-Rx Pharmaceuticals, Inc.

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