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Amlodipine

Generic Name: Amlodipine besylate
Dosage Form: tablet

Medically reviewed on Dec 1, 2018

How Supplied/Storage and Handling

2.5 mg Tablets
Amlodipine Besylate Tablets USP, 2.5 mg (Amlodipine besylate USP equivalent to 2.5 mg of Amlodipine per tablet) are supplied as white, round, flat face beveled edge tablets debossed on  one side and “20” on the other side and supplied as follows
NDC 62980-506-01       Bottle of 90 tablets
NDC 62980-506-02       Bottle of 300 tablets
NDC 62980-506-03       Bottle of 500 tablets
NDC 62980-506-04       Bottle of 1000 tablets

5 mg Tablets
Amlodipine Besylate Tablets USP, 5 mg (Amlodipine besylate USP equivalent to 5 mg of Amlodipine per tablet) are supplied as white, round, flat face beveled edge tablets debossed on  one side and “21” on the other side and supplied as follows:
NDC 62980-507-01       Bottle of 90 tablets
NDC 62980-507-02       Bottle of 300 tablets
NDC 62980-507-03       Bottle of 500 tablets
NDC 62980-507-04       Bottle of 1000 tablets

10 mg Tablets
Amlodipine Besylate Tablets USP, 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white, round, flat face beveled edge tablets debossed 22” on one side and plain on the other side and supplied as follows:
NDC 62980-508-01      Bottle of 90 tablets
NDC 62980-508-02      Bottle of 300 tablets
NDC 62980-508-03      Bottle of 500 tablets
NDC 62980-508-04      Bottle of 1000 tablets

Storage

Store bottles at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP).

PRINCIPAL DISPLAY PANEL

NDC 62980-506-01
Amlodipine Besylate Tablets USP
2.5 mg
PHARMACIST: Dispense with Patient Information Leaflet.
Rx only
90 Tablets

Vivimed

NDC 62980-507-01

Amlodipine Besylate Tablets USP
5 mg
PHARMACIST: Dispense with Patient Information Leaflet.
Rx only
90 Tablets

Vivimed

NDC 62980-508-01

Amlodipine Besylate Tablets USP
10 mg
PHARMACIST: Dispense with Patient Information Leaflet.
Rx only
90 Tablets

Vivimed

Amlodipine BESYLATE  2.5 MG
Amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62980-506
Route of Administration ORAL, ORAL, ORAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine BESYLATE (Amlodipine) Amlodipine 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
Product Characteristics
Color white Score no score
Shape ROUND (flat face beveled edge) Size 6mm
Flavor Imprint Code V;20
Contains     
Packaging
# Item Code Package Description
1 NDC:62980-506-01 90 TABLET in 1 BOTTLE
2 NDC:62980-506-02 300 TABLET in 1 BOTTLE
3 NDC:62980-506-03 500 TABLET in 1 BOTTLE
4 NDC:62980-506-04 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077516 04/01/2015
Amlodipine BESYLATE  5 MG
Amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62980-507
Route of Administration ORAL, ORAL, ORAL, ORAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine BESYLATE (Amlodipine) Amlodipine 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
Product Characteristics
Color white Score no score
Shape ROUND (flat face beveled edge) Size 8mm
Flavor Imprint Code V;21
Contains     
Packaging
# Item Code Package Description
1 NDC:62980-507-01 90 TABLET in 1 BOTTLE
2 NDC:62980-507-02 300 TABLET in 1 BOTTLE
3 NDC:62980-507-03 500 TABLET in 1 BOTTLE
4 NDC:62980-507-04 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077516 04/01/2015
Amlodipine BESYLATE  10 MG
Amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62980-508
Route of Administration ORAL, ORAL, ORAL, ORAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine BESYLATE (Amlodipine) Amlodipine 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
Product Characteristics
Color white Score no score
Shape ROUND (flat face beveled edge) Size 12mm
Flavor Imprint Code V22
Contains     
Packaging
# Item Code Package Description
1 NDC:62980-508-01 90 TABLET in 1 BOTTLE
2 NDC:62980-508-02 300 TABLET in 1 BOTTLE
3 NDC:62980-508-03 500 TABLET in 1 BOTTLE
4 NDC:62980-508-04 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077516 04/01/2015
Labeler - Vivimed Labs Limited (650210664)
Registrant - Strides Vivimed Pte. Ltd. (659263057)
Establishment
Name Address ID/FEI Operations
Vivimed Life Sciences Private Limited 860477684 analysis(62980-506, 62980-507, 62980-508), manufacture(62980-506, 62980-507, 62980-508), pack(62980-506, 62980-507, 62980-508)
 
Vivimed Labs Limited
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