Trimipramine Maleate (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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TRIMIPRAMINE MALEATE
trimipramine maleate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-293
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIMIPRAMINE MALEATE (TRIMIPRAMINE) TRIMIPRAMINE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C BLUE NO. 1
FD&C RED NO. 40
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
SHELLAC
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (opaque) , BLUE (opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code A;293
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-293-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:45963-293-08 90 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:45963-293-27 270 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077361 11/21/2011
TRIMIPRAMINE MALEATE
trimipramine maleate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-294
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIMIPRAMINE MALEATE (TRIMIPRAMINE) TRIMIPRAMINE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C BLUE NO. 1
FD&C RED NO. 40
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
SHELLAC
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (opaque) , BLUE (opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code A;294
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-294-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:45963-294-08 90 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:45963-294-27 270 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077361 11/21/2011
TRIMIPRAMINE MALEATE
trimipramine maleate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-295
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIMIPRAMINE MALEATE (TRIMIPRAMINE) TRIMIPRAMINE 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C BLUE NO. 1
FD&C RED NO. 40
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
SHELLAC
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (opaque) , BLUE (light opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code A;295
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-295-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077361 10/21/2011
Labeler — Actavis Inc. (099262404)
Registrant — Mikah Pharma LLC (078420272)
Establishment
Name Address ID/FEI Operations
Epic Pharma LLC 827915443 MANUFACTURE (45963-293), MANUFACTURE (45963-294), MANUFACTURE (45963-295)

Revised: 12/2012 Actavis Inc.

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