NDC Code(s) : 60951-185-30, 60951-185-92, 60951-185-90, 60951-185-70, 60951-186-30, 60951-186-92, 60951-186-90, 60951-186-70, 60951-187-30, 60951-187-92, 60951-187-90, 60951-187-70
Packager : Par Pharmaceutical

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Losartan Potassium Losartan Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-185
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM(UNII: 3ST302B24A)
(LOSARTAN - UNII:JMS50MPO89) 		LOSARTAN POTASSIUM25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color GREEN Score no score
Shape ROUND (Circular, biconvex) Size 6 mm
Flavor Imprint Code L143
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-185-3030 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
2NDC:60951-185-9290 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
3NDC:60951-185-901000 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
4NDC:60951-185-70100 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090428 11/12/2010 07/31/2012
Losartan Potassium Losartan Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-186
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM(UNII: 3ST302B24A)
(LOSARTAN - UNII:JMS50MPO89) 		LOSARTAN POTASSIUM50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND (Circular, biconvex) Size 8 mm
Flavor Imprint Code L142
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-186-3030 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
2NDC:60951-186-9290 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
3NDC:60951-186-901000 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
4NDC:60951-186-70100 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090428 11/12/2010 07/31/2012
Losartan Potassium Losartan Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60951-187
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM(UNII: 3ST302B24A)
(LOSARTAN - UNII:JMS50MPO89) 		LOSARTAN POTASSIUM100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color GREEN Score no score
Shape ROUND (Circular, biconvex) Size 11 mm
Flavor Imprint Code L126
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60951-187-3030 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
2NDC:60951-187-9290 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
3NDC:60951-187-901000 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
4NDC:60951-187-70100 in 1 BOTTLE Type 0: Not a Combination Product12/11/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090428 11/12/2010 07/31/2012

PRINCIPAL DISPLAY PANEL


Losartan Potassium Tablets USP 25 mg (90 Tablets in HDPE bottle)
Each film coated tablet contains: Losartan Potassium USP...... 25 mg
60951-185-92


25mg 90

PRINCIPAL DISPLAY PANEL

Losartan Potassium Tablets USP 50 mg (90 Tablets in HDPE bottle)
Each film coated tablet contains: Losartan Potassium USP...... 50 mg 
60951-186-92


50mg 90

PRINCIPAL DISPLAY PANEL

Losartan Potassium Tablets USP 100 mg (90 Tablets in HDPE bottle)
Each film coated tablet contains: Losartan Potassium USP..... 100 mg 
60951-187-92 


100mg 90