Benicar (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 65597-101-30
TABLETS
Benicar
(olmesartan medoxomil)
5 mg
30 TABLETSRx Only

PRINCIPAL DISPLAY PANEL NDC 65597-101-30 TABLETS Benicar (olmesartan medoxomil) 5 mg 30 TABLETS Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 65597-103-30
TABLETS
Benicar
(olmesartan medoxomil)
20 mg
30 TABLETSRx Only

PRINCIPAL DISPLAY PANEL NDC 65597-103-30 TABLETS Benicar (olmesartan medoxomil) 20 mg 30 TABLETS Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 65597-104-30
TABLETS
Benicar
(olmesartan medoxomil)
40 mg
30 TABLETSRx Only

PRINCIPAL DISPLAY PANEL NDC 65597-104-30 TABLETS Benicar (olmesartan medoxomil) 40 mg 30 TABLETS Rx Only
(click image for full-size original)
BENICAR olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 5 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code Sankyo;C12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-101-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021286 04/25/2002 01/31/2024
BENICAR olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-103
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code Sankyo;C14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-103-03 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None
2 NDC:65597-103-06 180 TABLET, FILM COATED in 1 BOX None
3 NDC:65597-103-10 100 TABLET, FILM COATED in 1 BOX None
4 NDC:65597-103-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:65597-103-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021286 04/25/2002 03/31/2024
BENICAR olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-104
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Sankyo;C15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-104-03 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None
2 NDC:65597-104-06 180 TABLET, FILM COATED in 1 BOX None
3 NDC:65597-104-10 100 TABLET, FILM COATED in 1 BOX None
4 NDC:65597-104-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:65597-104-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021286 04/25/2002 03/31/2024
Labeler — Daiichi Sankyo, Inc. (068605067)
Establishment
Name Address ID/FEI Operations
Packaging Coordinators, LLC 078525133 LABEL (65597-101), LABEL (65597-103), LABEL (65597-104), PACK (65597-101), PACK (65597-103), PACK (65597-104)

Revised: 06/2022 Daiichi Sankyo, Inc.

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