Olmesartan Medoxomil

OLMESARTAN MEDOXOMIL- olmesartan medoxomil tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1059-1

Olmesartan Medoxomil Tablets, 5 mg

Rx only

100 TABLETS

structured formula of olmesartan-image03
(click image for full-size original)

NDC 70771-1060-1

Olmesartan Medoxomil Tablets, 20 mg

Rx only

100 TABLETS

structured formula of olmesartan-image04
(click image for full-size original)

NDC 70771-1061-1

Olmesartan Medoxomil Tablets, 40 mg

Rx only

100 TABLETS

structured formula of olmesartan-image05
(click image for full-size original)
OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1059
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)
HYPROMELLOSES
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
STEARIC ACID
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 643
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1059-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1059-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1059-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1059-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1059-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1059-7 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1059-2)
6 NDC:70771-1059-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1059-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205192 04/24/2017
OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1060
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)
HYPROMELLOSES
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
STEARIC ACID
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 644
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1060-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1060-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1060-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1060-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1060-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1060-7 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1060-2)
6 NDC:70771-1060-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1060-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205192 04/24/2017
OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1061
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)
HYPROMELLOSES
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
STEARIC ACID
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 15mm
Flavor Imprint Code 645
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1061-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1061-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1061-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1061-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1061-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1061-7 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1061-2)
6 NDC:70771-1061-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1061-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205192 04/24/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (863362789)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1059), ANALYSIS (70771-1060), ANALYSIS (70771-1061), MANUFACTURE (70771-1059), MANUFACTURE (70771-1060), MANUFACTURE (70771-1061)

Revised: 09/2020 Cadila Healthcare Limited

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