NDC Code(s) : 0378-4041-77, 0378-4042-93, 0378-4042-77, 0378-4043-93, 0378-4043-77
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Losartan Potassiumlosartan potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4041
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
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 7 mm
Flavor Imprint Code M;LN25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-4041-7790 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product06/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091590 10/06/2010 05/31/2013
Losartan Potassiumlosartan potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4042
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
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code M;LN;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-4042-9330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product06/10/2010
2NDC:0378-4042-7790 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product06/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091590 10/06/2010 07/31/2013
Losartan Potassiumlosartan potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4043
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
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code M;LN100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-4043-9330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product06/10/2010
2NDC:0378-4043-7790 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product06/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091590 10/06/2010 07/31/2013

PRINCIPAL DISPLAY PANEL

NDC 0378-4041-77

Losartan
Potassium
Tablets, USP
25 mg

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Rx only     90 Tablets

Each film-coated tablet contains:
Losartan potassium, USP 25 mg

Usual Dosage: See accompanying
prescribing information.

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

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

Protect from light.

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

Made in India

Mylan.com

RMX4041MM2

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Losartan Potassium Tablets, USP 25 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-4042-93

Losartan
Potassium
Tablets, USP
50 mg

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Rx only     30 Tablets

Each film-coated tablet contains:
Losartan potassium, USP 50 mg

Usual Dosage: See accompanying
prescribing information.

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

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

Protect from light.

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

Made in India

Mylan.com

RMX4042H2

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Losartan Potassium Tablets, USP 50 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-4043-93

Losartan
Potassium
Tablets, USP
100 mg

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Rx only     30 Tablets

Each film-coated tablet contains:
Losartan potassium, USP 100 mg

Usual Dosage: See accompanying
prescribing information.

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

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

Protect from light.

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

Made in India

Mylan.com

RMX4043H2

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Losartan Potassium Tablets, USP 100 mg Bottle Label