AMLODIPINE BESYLATE TABLETS, USP for oral administration Initial U.S. Approval: 1992

AMLODIPINE BESYLATE by

Drug Labeling and Warnings

AMLODIPINE BESYLATE by is a Prescription medication manufactured, distributed, or labeled by Vivimed Labs Limited, Strides Vivimed Pte. Ltd., Vivimed Life Sciences Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AMLODIPINE BESYLATE 2.5 MG- amlodipine besylate tablet 
AMLODIPINE BESYLATE 5 MG- amlodipine besylate tablet 
AMLODIPINE BESYLATE 10 MG- amlodipine besylate tablet 
Vivimed Labs Limited

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AMLODIPINE BESYLATE TABLETS, USP for oral administration

Initial U.S. Approval: 1992

HOW SUPPLIED

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 "V" 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 "V" 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 "V" one side and "22" 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).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 62980-506-01Amlodipine Besylate Tablets USP

2.5 mg

PHARMACIST: Dispense with Patient Information Leaflet

Rx only

90 Tablets

Vivimed

image04

NDC: 62980-507-01

Amlodipine Besylate Tablets USP

5 mg

PHARMACIST: Dispense with Patient Information Leaflet

Rx only

90 Tablets

Vivimed

image05

NDC: 62980-508-01

Amlodipine Besylate Tablets USP

10 mg

PHARMACIST: Dispense with Patient Information Leaflet

Rx only

90 Tablets

Vivimed

image06
AMLODIPINE BESYLATE  2.5 MG
amlodipine besylate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62980-506
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE2.5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (flat face beveled edge) Size6mm
FlavorImprint Code V;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62980-506-0190 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201511/26/2019
2NDC: 62980-506-02300 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201511/26/2019
3NDC: 62980-506-03500 in 1 BOTTLE; Type 0: Not a Combination Product08/12/201711/26/2019
4NDC: 62980-506-041000 in 1 BOTTLE; Type 0: Not a Combination Product08/12/201711/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751604/01/201511/26/2019
AMLODIPINE BESYLATE  5 MG
amlodipine besylate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62980-507
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (flat face beveled edge) Size8mm
FlavorImprint Code V;21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62980-507-0190 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201511/26/2019
2NDC: 62980-507-02300 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201511/26/2019
3NDC: 62980-507-03500 in 1 BOTTLE; Type 0: Not a Combination Product08/12/201711/26/2019
4NDC: 62980-507-041000 in 1 BOTTLE; Type 0: Not a Combination Product08/12/201711/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751604/01/201511/26/2019
AMLODIPINE BESYLATE  10 MG
amlodipine besylate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62980-508
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (flat face beveled edge) Size12mm
FlavorImprint Code V22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62980-508-0190 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201511/26/2019
2NDC: 62980-508-02300 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201511/26/2019
3NDC: 62980-508-03500 in 1 BOTTLE; Type 0: Not a Combination Product08/12/201711/26/2019
4NDC: 62980-508-041000 in 1 BOTTLE; Type 0: Not a Combination Product08/12/201711/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751604/01/201511/26/2019
Labeler - Vivimed Labs Limited (650210664)
Establishment
NameAddressID/FEIBusiness Operations
Vivimed Life Sciences Private Limited860477684ANALYSIS(62980-506, 62980-507, 62980-508) , MANUFACTURE(62980-506, 62980-507, 62980-508)

Revised: 11/2019
Document Id: 1b9dc9c3-2317-4297-a46a-76c2ce604ccb
Set id: 4b0616ab-8d0a-4310-b6b1-5d22c32a4da5
Version: 3
Effective Time: 20191126
 
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