NDC Code(s) : 0527-2425-32, 0527-2425-46, 0527-2426-32, 0527-2426-46, 0527-2427-32, 0527-2427-46
Packager : Lannett Company, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OLMESARTAN MEDOXOMILOlmesartan medoxomil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2425
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD)
(OLMESARTAN - UNII:8W1IQP3U10) 		OLMESARTAN MEDOXOMIL5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
Color white Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code L20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0527-2425-3230 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/05/2019
2NDC:0527-2425-4690 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211049 03/05/2019
OLMESARTAN MEDOXOMILOlmesartan medoxomil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2426
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD)
(OLMESARTAN - UNII:8W1IQP3U10) 		OLMESARTAN MEDOXOMIL20 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
Color white Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code L18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0527-2426-3230 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/05/2019
2NDC:0527-2426-4690 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211049 03/05/2019
OLMESARTAN MEDOXOMILOlmesartan medoxomil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2427
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD)
(OLMESARTAN - UNII:8W1IQP3U10) 		OLMESARTAN MEDOXOMIL40 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
Color white Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code L17
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0527-2427-3230 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/05/2019
2NDC:0527-2427-4690 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211049 03/05/2019

LABELER - Lannett Company, Inc.(002277481)

REGISTRANT - Sunshine Lake Pharma Co., Ltd.(545391443)

Establishment
Name Address ID/FEI Business Operations
Sunshine Lake Pharma Co., Ltd. 545391443 manufacture(0527-2425, 0527-2426, 0527-2427)

PRINCIPAL DISPLAY PANEL

Olmesartan medoxomil Tablets - Package Label - 5 mg 30 ct Bottle Label

PRINCIPAL DISPLAY PANEL

20 mg 30 ct Bottle Label

PRINCIPAL DISPLAY PANEL

Olmesartan medoxomil Tablets - Package Label - 40 mg 30 ct Bottle Label