AMLODIPINE BESYLATE- amlodipine besylate tablet 
Cadila Healthcare Limited

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AMLODIPINE Besylate Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-620-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 2.5 mg

Rx only

90 tablets

Amlodipine Besylate Tablets USP, 2.5 mg

NDC 65841-621-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 5 mg

Rx only

90 tablets

Amlodipine Besylate Tablets USP, 5 mg

NDC 65841-622-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 10 mg

Rx only

90 tablets

Amlodipine Besylate Tablets USP, 10 mg
AMLODIPINE BESYLATE 
amlodipine besylate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-620
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size4mm
FlavorImprint Code Z;7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-620-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
2NDC:65841-620-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
3NDC:65841-620-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
4NDC:65841-620-7710 in 1 CARTON09/21/2007
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07822609/21/2007
AMLODIPINE BESYLATE 
amlodipine besylate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-621
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code Z;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-621-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
2NDC:65841-621-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
3NDC:65841-621-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
4NDC:65841-621-7710 in 1 CARTON09/21/2007
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07822609/21/2007
AMLODIPINE BESYLATE 
amlodipine besylate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-622
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code Z;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-622-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
2NDC:65841-622-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
3NDC:65841-622-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
4NDC:65841-622-7710 in 1 CARTON09/21/2007
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07822609/21/2007
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622)

Revised: 8/2020
Document Id: 8605c9cc-c3d4-4d59-83ca-7f0fc26c4eb3
Set id: cacb3551-c579-41cb-bed6-4b4d8b0644fc
Version: 10
Effective Time: 20200805
 
Cadila Healthcare Limited