Prescription Drug Information: Doxepin Hydrochloride (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 3 mg Tablet Bottle Label

NDC 44183-103-30

Doxepin HCl Tablets

3 mg

Dispense the accompanying Medication Guide to each patient.

Rx Only

30 TABLETS

MACOVEN

PRINCIPAL DISPLAY PANEL -- 3 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 6 mg Tablet Bottle Label

NDC 44183-106-30

Doxepin HCl Tablets

6 mg

Dispense the accompanying Medication Guide to each patient.

Rx Only

30 TABLETS

MACOVEN

PRINCIPAL DISPLAY PANEL -- 6 mg Tablet Bottle Label
(click image for full-size original)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44183-103
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doxepin hydrochloride (doxepin) doxepin 3 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
silicon dioxide
magnesium stearate
FD&C Blue No. 1
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 3;SP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44183-103-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA022036 08/01/2010
DOXEPIN HYDROCHLORIDE doxepin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44183-106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doxepin hydrochloride (doxepin) doxepin 6 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
silicon dioxide
magnesium stearate
FD&C Blue No. 1
D&C Yellow No. 10
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 6;SP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44183-106-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA022036 08/01/2010
Labeler — Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven (117055730)
Establishment
Name Address ID/FEI Operations
Patheon Pharmaceuticals, Inc 005286822 MANUFACTURE (44183-103), MANUFACTURE (44183-106)
Establishment
Name Address ID/FEI Operations
Plantex Ltd 600023907 API MANUFACTURE (44183-103), API MANUFACTURE (44183-106)
Establishment
Name Address ID/FEI Operations
Ropack Inc. 209989631 PACK (44183-103), PACK (44183-106)
Establishment
Name Address ID/FEI Operations
Teva API India Private Ltd. 677604426 API MANUFACTURE (44183-103), ANALYSIS (44183-106)

Revised: 01/2022 Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven

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