Olmesartan Medoxomil (Page 5 of 5)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (90 Tablet Bottle)

90 Tablets NDC 82009-074-90
Olmesartan Medoxomil
Tablets, USP
Rx only 20 mg
Quallent
Pharmaceuticals℠

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (30 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg (90 Tablet Bottle)

90 Tablets NDC 82009-075-90
Olmesartan Medoxomil
Tablets, USP
Rx only 40 mg
Quallent
Pharmaceuticals

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg (90 Tablet Bottle)
(click image for full-size original)

OLMESARTAN MEDOXOMIL olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-073
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 (110000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code K;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-073-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204798 08/01/2023
OLMESARTAN MEDOXOMIL olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-074
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 (110000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code K;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-074-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204798 08/01/2023
OLMESARTAN MEDOXOMIL olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-075
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 (110000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL (Biconvex) Size 15mm
Flavor Imprint Code K;19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-075-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204798 08/01/2023
Labeler — QUALLENT PHARMACEUTICALS HEALTH LLC (815564528)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (82009-073), ANALYSIS (82009-074), ANALYSIS (82009-075), MANUFACTURE (82009-073), MANUFACTURE (82009-074), MANUFACTURE (82009-075)

Revised: 06/2023 QUALLENT PHARMACEUTICALS HEALTH LLC

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