Amlodipine Besylate and Benazepril Hydrochloride (Page 7 of 7)

2.5-10mg

Package Label – 2.5 mg/ 10 mg

2.5 mg/ 10 mg
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2.5 mg/ 10 mg
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2.5 mg/ 10 mg
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5-10mg

Package Label – 5 mg/ 10 mg

5 mg/ 10 mg
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5 mg/ 10 mg
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5 mg/ 10 mg
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5-20mg

Package Label – 5 mg/ 20 mg

5 mg/ 20 mg
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5 mg/ 20 mg
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5 mg/ 20 mg
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5-40mg

Package Label – 5 mg/ 40 mg

5 mg/ 40 mg
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5 mg/ 40 mg
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5 mg/ 40 mg
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10-20mg

Package Label – 10 mg/ 20 mg

10 mg/ 20 mg
(click image for full-size original)

10 mg/ 20 mg
(click image for full-size original)

10 mg/ 20 mg
(click image for full-size original)

10-40mg

Package Label – 10 mg/ 40 mg

10 mg/ 40 mg
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10 mg/ 40 mg
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10 mg/ 40 mg
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AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-2271(NDC:0781-2271)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
HYPROMELLOSES
SILICON DIOXIDE
CROSPOVIDONE
GELATIN
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white with 2 gold bands) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code S;SANDOZ;571
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-2271-9 90 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:58118-2271-3 30 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:58118-2271-8 30 CAPSULE in 1 BLISTER PACK None
4 NDC:58118-2271-0 1 CAPSULE in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020364 03/03/1995
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-2272(NDC:0781-2272)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
HYPROMELLOSES
CROSPOVIDONE
GELATIN
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color BROWN (light brown with 2 white bands) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code S;SANDOZ;572
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-2272-9 90 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:58118-2272-3 30 CAPSULE (1000 CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:58118-2272-8 30 CAPSULE in 1 BLISTER PACK None
4 NDC:58118-2272-0 1 CAPSULE in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020364 03/03/1995
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-2273(NDC:0781-2273)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
HYPROMELLOSES
SILICON DIOXIDE
CROSPOVIDONE
GELATIN
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
STARCH, CORN
Product Characteristics
Color PINK (pink with 2 white bands) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code S;SANDOZ;573
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-2273-9 90 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:58118-2273-3 30 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:58118-2273-8 30 CAPSULE in 1 BLISTER PACK None
4 NDC:58118-2273-0 1 CAPSULE (1000 CAPSULE) in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020364 03/03/1995
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-2274(NDC:0781-2274)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
HYPROMELLOSES
CROSPOVIDONE
GELATIN
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PURPLE (purple with 2 white bands) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code S;SANDOZ;574
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-2274-9 90 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:58118-2274-3 30 CAPSULE (1000 CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:58118-2274-8 30 CAPSULE in 1 BLISTER PACK None
4 NDC:58118-2274-0 1 CAPSULE in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020364 03/03/1995
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-2277(NDC:0781-2277)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
HYPROMELLOSES
SILICON DIOXIDE
CROSPOVIDONE
GELATIN
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color BLUE (light blue with 2 white bands) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code S;SANDOZ;577
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-2277-9 90 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:58118-2277-3 30 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:58118-2277-8 30 CAPSULE in 1 BLISTER PACK None
4 NDC:58118-2277-0 1 CAPSULE in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020364 03/03/1995
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-2279(NDC:0781-2279)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
HYPROMELLOSES
CROSPOVIDONE
GELATIN
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (dark blue with 2 white bands) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code S;SANDOZ;578
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-2279-9 90 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:58118-2279-3 30 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:58118-2279-8 30 CAPSULE in 1 BLISTER PACK None
4 NDC:58118-2279-0 1 CAPSULE in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020364 03/03/1995
Labeler — Clinical Solutions Wholesale (078710347)
Registrant — Clinical Solutions Wholesale (078710347)
Establishment
Name Address ID/FEI Operations
Clinical Solutions Wholesale 078710347 repack (58118-2271), relabel (58118-2271), repack (58118-2272), relabel (58118-2272), repack (58118-2273), relabel (58118-2273), repack (58118-2274), relabel (58118-2274), repack (58118-2277), relabel (58118-2277), repack (58118-2279), relabel (58118-2279)

Revised: 08/2013 Clinical Solutions Wholesale

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