Amlodipine Besylate (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2.5 mg : label

2.5 mg
(click image for full-size original)

5 mg : label

5 mg
(click image for full-size original)

10 mg : label

10 mg
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-022
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (White) Score no score
Shape ROUND (circular) Size 6mm
Flavor Imprint Code 1022;2;5mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-022-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-022-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-022-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-022-03 300 TABLET in 1 BOTTLE None
5 NDC:13668-022-05 500 TABLET in 1 BOTTLE None
6 NDC:13668-022-10 1000 TABLET in 1 BOTTLE None
7 NDC:13668-022-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078573 02/05/2009
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-023
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (White) Score no score
Shape ROUND (circular) Size 8mm
Flavor Imprint Code 1023;5mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-023-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-023-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-023-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-023-03 300 TABLET in 1 BOTTLE None
5 NDC:13668-023-05 500 TABLET in 1 BOTTLE None
6 NDC:13668-023-10 1000 TABLET in 1 BOTTLE None
7 NDC:13668-023-48 4100 TABLET in 1 BOTTLE None
8 NDC:13668-023-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078573 02/05/2009
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-024
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (White) Score no score
Shape ROUND (circular) Size 10mm
Flavor Imprint Code 1024;10mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-024-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-024-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-024-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-024-03 300 TABLET in 1 BOTTLE None
5 NDC:13668-024-05 500 TABLET in 1 BOTTLE None
6 NDC:13668-024-10 1000 TABLET in 1 BOTTLE None
7 NDC:13668-024-20 2000 TABLET in 1 BOTTLE None
8 NDC:13668-024-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078573 02/05/2009
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-022), manufacture (13668-023), manufacture (13668-024)

Revised: 01/2021 Torrent Pharmaceuticals Limited

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