Doxepin Hydrochloride (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 51079-436-20

Doxepin HCl
Capsules, USP
10 mg*

100 Capsules (10 x 10)

*Each capsule contains doxepin
hydrochloride, USP equivalent to
10 mg of doxepin.

Usual Daily Dosage: Mild to moderate
symptomatology: 75 mg to
150 mg. Severe symptomatology:
150 mg to 300 mg. See Medication
Guide and package insert for complete
dosage information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-3840 R9

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Doxepin HCl 10 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg

NDC 51079-437-20

Doxepin HCl
Capsules, USP
25 mg*

100 Capsules (10 x 10)

*Each capsule contains doxepin
hydrochloride, USP equivalent to
25 mg of doxepin.

Usual Daily Dosage: Mild to moderate
symptomatology: 75 mg to
150 mg. Severe symptomatology:
150 mg to 300 mg. See Medication Guide
and package insert for complete dosage information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-3841 R9

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Doxepin HCl 25 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg

NDC 51079-438-20

Doxepin HCl
Capsules, USP
50 mg*

100 Capsules (10 x 10)

*Each capsule contains doxepin
hydrochloride, USP equivalent to
50 mg of doxepin.

Usual Daily Dosage: Mild to moderate
symptomatology: 75 mg to
150 mg. Severe symptomatology:
150 mg to 300 mg. See package insert
and Medication Guide for complete dosage information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-3842 R8

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Doxepin HCl 50 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg

NDC 51079-651-20

Doxepin HCl
Capsules, USP
100 mg*

100 Capsules (10 x 10)

*Each capsule contains doxepin
hydrochloride, USP equivalent to
100 mg of doxepin.

Usual Daily Dosage: Mild to moderate
symptomatology: 75 mg to
150 mg. Severe symptomatology:
150 mg to 300 mg. See Medication Guide
and package insert for complete dosage information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-3844 R8

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Doxepin HCl 100 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-437(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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
GELATIN
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:51079-437-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-437-01)
1 NDC:51079-437-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-437-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070791 05/08/1998
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-436(NDC:0378-1049)
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
GELATIN
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 (buff opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;1049
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-436-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-436-01)
1 NDC:51079-436-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-436-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070791 06/12/1998
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-438(NDC:0378-4250)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
GELATIN
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) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code MYLAN;4250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-438-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-438-01)
1 NDC:51079-438-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-438-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070791 05/28/1998
DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-651(NDC:0378-6410)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
GELATIN
TITANIUM DIOXIDE
FD&C GREEN NO. 3
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color green (brite lite green opaque) , white (White Opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code MYLAN;6410
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-651-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-651-01)
1 NDC:51079-651-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-651-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070791 06/02/1998
Labeler — Mylan Institutional Inc. (039615992)

Revised: 11/2016 Mylan Institutional Inc.

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