Anafranil, Page 5

Anafranil (clomipramine hydrochloride), is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Anafranil is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD).

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 25 mg Bottle

NDC 0406-9906-03
30 Capsules
Anafranilâ„¢
Clomipramine Hydrochloride Capsules USP

25 mg
Rx only
Each capsule contains:
Clomipramine Hydrochloride USP … 25 mg
PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE
MALLINCKRODT

Principal Display Panel -- 25 mg bottle
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 50 mg Bottle

NDC 0406-9907-03
30 Capsules
Anafranilâ„¢
Clomipramine Hydrochloride Capsules USP

50 mg
Rx only
Each capsule contains:
Clomipramine Hydrochloride USP … 50 mg
PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE
MALLINCKRODT

Principal Display Panel -- 50 mg bottle
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 75 mg Bottle

NDC 0406-9908-03
30 Capsules
Anafranilâ„¢
Clomipramine Hydrochloride Capsules USP

75 mg
Rx only
Each capsule contains:
Clomipramine Hydrochloride USP … 75 mg
PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE
MALLINCKRODT

Principal Display Panel -- 75 mg bottle
(click image for full-size original)

ANAFRANIL
clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0406-9906
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
METHYLPARABEN
PROPYLPARABEN
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white (ivory) , yellow (melon) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code M;ANAFRANIL;25;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0406-9906-03 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019906 03/18/2011
ANAFRANIL
clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0406-9907
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
METHYLPARABEN
PROPYLPARABEN
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white (ivory) , blue (aqua) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code M;ANAFRANIL;50;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0406-9907-03 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019906 03/18/2011
ANAFRANIL
clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0406-9908
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
METHYLPARABEN
PROPYLPARABEN
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white (ivory) , yellow (yellow) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code M;ANAFRANIL;75;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0406-9908-03 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019906 03/18/2011
Labeler — Mallinckrodt Inc. (047021092)
Establishment
Name Address ID/FEI Operations
Patheon Inc. 205475333 manufacture

Revised: 03/2011 Mallinckrodt Inc.

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