Amlodipine Besylate (Page 6 of 6)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-620
Route of Administration 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
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 4mm
Flavor Imprint Code Z;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-620-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-620-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-620-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-620-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-620-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078226 09/21/2007
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-621
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code Z;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-621-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-621-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-621-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-621-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-621-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078226 09/21/2007
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-622
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code Z;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-622-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-622-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-622-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-622-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-622-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078226 09/21/2007
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (65841-620), ANALYSIS (65841-621), ANALYSIS (65841-622), MANUFACTURE (65841-620), MANUFACTURE (65841-621), MANUFACTURE (65841-622)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-620), ANALYSIS (65841-621), ANALYSIS (65841-622), MANUFACTURE (65841-620), MANUFACTURE (65841-621), MANUFACTURE (65841-622)

Revised: 11/2019 Cadila Healthcare Limited

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