Amlodipine Besylate and Atorvastatin Calcium (Page 13 of 13)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5/10 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container1
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Amlodipine besylate and Atorvastatin calcium Tablets, 2.5/20 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

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Amlodipine besylate and Atorvastatin calcium Tablets, 2.5/40 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

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Amlodipine besylate and Atorvastatin calcium Tablets, 5/10 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

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Amlodipine besylate and Atorvastatin calcium Tablets, 5/20 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container5
(click image for full-size original)

Amlodipine besylate and Atorvastatin calcium Tablets, 5/40 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container6
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Amlodipine besylate and Atorvastatin calcium Tablets, 5/80 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container7
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Amlodipine besylate and Atorvastatin calcium Tablets, 10/10 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container8
(click image for full-size original)

Amlodipine besylate and Atorvastatin calcium Tablets, 10/20 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container9
(click image for full-size original)

Amlodipine besylate and Atorvastatin calcium Tablets, 10/40 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container10
(click image for full-size original)

Amlodipine besylate and Atorvastatin calcium Tablets, 10/80 mg- Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

container11
(click image for full-size original)
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-323
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 2.5 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 3mm
Flavor Imprint Code R;407
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-323-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-323-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-323-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-323-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 2.5 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 20 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 4mm
Flavor Imprint Code R;408
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-320-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-320-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-320-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-320-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-317
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 2.5 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 40 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code R;409
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-317-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-317-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-317-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-317-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-322
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 5 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 3mm
Flavor Imprint Code R;410
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-322-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-322-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-322-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-322-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-319
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 5 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 20 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 5mm
Flavor Imprint Code R;411
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-319-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-319-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-319-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-319-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-316
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 5 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 40 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 6mm
Flavor Imprint Code R;412
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-316-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-316-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-316-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-316-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-314
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 5 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 80 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 7mm
Flavor Imprint Code R;413
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-314-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-314-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-314-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-314-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-321
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 10 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 3mm
Flavor Imprint Code R;414
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-321-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-321-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-321-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-321-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-318
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 10 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 20 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 5mm
Flavor Imprint Code R;415
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-318-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-318-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-318-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-318-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-315
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 10 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 40 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 6mm
Flavor Imprint Code R;416
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-315-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-315-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-315-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-315-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-313
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amlodipine besylate (amlodipine) amlodipine 10 mg
Atorvastatin Calcium Trihydrate (atorvastatin) atorvastatin 80 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Crospovidone
Hydroxypropyl Cellulose, Unspecified
magnesium stearate
cellulose, microcrystalline
starch, corn
sodium bicarbonate
sodium lauryl sulfate
polyethylene glycol 3350
Polyvinyl Alcohol, Unspecified
Hydrogenated Soybean Lecithin
talc
titanium dioxide
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 7mm
Flavor Imprint Code R;417
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-313-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-313-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-313-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-313-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203874 03/17/2014
Labeler — Dr. Reddy’s Laboratories Inc (802315887)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited-FTO3 918608162 manufacture (43598-323), manufacture (43598-320), manufacture (43598-317), manufacture (43598-322), manufacture (43598-319), manufacture (43598-316), manufacture (43598-314), manufacture (43598-321), manufacture (43598-318), manufacture (43598-315), manufacture (43598-313), analysis (43598-323), analysis (43598-320), analysis (43598-317), analysis (43598-319), analysis (43598-316), analysis (43598-314), analysis (43598-321), analysis (43598-318), analysis (43598-315), analysis (43598-313), analysis (43598-322)

Revised: 02/2021 Dr. Reddy’s Laboratories Inc

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