Amlodipine Besylate and Benazepril Hydrochloride (Page 7 of 7)

Amlodipine besylate/ Benazepril HCl

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AMLODIPINE/BENAZEPRIL 2.5/10MG CAPSULE

Label Image
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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:63629-1454(NDC:55111-340)
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
SILICON DIOXIDE
CROSPOVIDONE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
HYDROGENATED CASTOR OIL
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C RED NO. 40
FD&C BLUE NO. 1
FERRIC OXIDE RED
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color gray (ivory) , orange Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY;340
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-1454-2 90 CAPSULE in 1 BOTTLE None
2 NDC:63629-1454-3 60 CAPSULE in 1 BOTTLE None
3 NDC:63629-1454-1 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077183 04/19/2010
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate and benazepril hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-7643(NDC:55111-338)
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
SILICON DIOXIDE
CROSPOVIDONE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
HYDROGENATED CASTOR OIL
FD&C GREEN NO. 3
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color gray (ivory) , blue (Bluish green) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY;338
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-7643-2 90 CAPSULE in 1 BOTTLE None
2 NDC:63629-7643-1 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077183 04/19/2010 11/21/2022
Labeler — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 repack (63629-7643), repack (63629-1454), relabel (63629-1454), relabel (63629-7643)

Revised: 11/2022 Bryant Ranch Prepack

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