Amlodipine Besylate and Benazepril Hydrochloride (Page 7 of 7)

Package/Label Display Panel

Amlodipine and Benazepril HCl Capsules USP 2.5mg/10mg

NDC 68001-132-00, 100 Capsules

NDC 68001-132-00
(click image for full-size original)

Package/Label Display Panel

Amlodipine and Benazepril HCl Capsules USP 5mg/10mg

NDC 68001-133-00

NDC 68001-133-00
(click image for full-size original)

Package/Label Display Panel

Amlodipine and Benazepril HCl Capsules USP 5mg/20mg

NDC 68001-134-00, 100 Capsules

NDC 68001-134-00
(click image for full-size original)

Package/Label Display Panel

Amlodipine and Benazepril HCl Capsules USP 5mg/40mg

NDC 68001-135-00, 100 Capsules

NDC 68001-135-00
(click image for full-size original)

Package/Label Display Panel

Amlodipine and Benazepril HCl Capsules USP 10mg/20mg

NDC 68001-130-00

NDC 68001-130-00
(click image for full-size original)

Package/Label Display Panel

Amlodipine and Benazepril HCl Capsules USP 10mg/40mg

NDC 68001-131-00, 100 Tablets

NDC 68001-131-00
(click image for full-size original)
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-132
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
ANHYDROUS LACTOSE
GELATIN, UNSPECIFIED
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
SHELLAC
POVIDONE, UNSPECIFIED
POTASSIUM HYDROXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (White Opaque Cap and White Opaque Body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-132-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078466 07/16/2015
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-133
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
ANHYDROUS LACTOSE
GELATIN, UNSPECIFIED
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
SHELLAC
POVIDONE, UNSPECIFIED
POTASSIUM HYDROXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN (Light Brown Opaque Cap and Light Brown Opaque Body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-133-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078466 07/16/2015
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-134
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
ANHYDROUS LACTOSE
GELATIN, UNSPECIFIED
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
SHELLAC
POVIDONE, UNSPECIFIED
POTASSIUM HYDROXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK (Flesh Opaque Cap and Flesh Opaque Body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-134-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078466 07/16/2015
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-135
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
ANHYDROUS LACTOSE
GELATIN, UNSPECIFIED
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
SHELLAC
POVIDONE, UNSPECIFIED
POTASSIUM HYDROXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color GREEN (dark green cap) , WHITE (white body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-135-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078466 07/16/2015
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-130
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
ANHYDROUS LACTOSE
GELATIN, UNSPECIFIED
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
SHELLAC
POVIDONE, UNSPECIFIED
POTASSIUM HYDROXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color PURPLE (Purple Cap and Purple Body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-130-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078466 07/16/2015
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-131
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
ANHYDROUS LACTOSE
GELATIN, UNSPECIFIED
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
SHELLAC
POVIDONE, UNSPECIFIED
POTASSIUM HYDROXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color BLUE (dark blue cap) , WHITE (white body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-131-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078466 07/16/2015
Labeler — BluePoint Laboratories (985523874)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68001-132), MANUFACTURE (68001-133), MANUFACTURE (68001-134), MANUFACTURE (68001-135), MANUFACTURE (68001-130), MANUFACTURE (68001-131), PACK (68001-132), PACK (68001-133), PACK (68001-134), PACK (68001-135), PACK (68001-130), PACK (68001-131)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 MANUFACTURE (68001-132), MANUFACTURE (68001-133), MANUFACTURE (68001-134), MANUFACTURE (68001-135), MANUFACTURE (68001-130), MANUFACTURE (68001-131), PACK (68001-132), PACK (68001-133), PACK (68001-134), PACK (68001-135), PACK (68001-130), PACK (68001-131)

Revised: 04/2020 BluePoint Laboratories

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