NDC Code(s) : 58118-2271-9, 58118-2271-3, 58118-2271-8, 58118-2271-0, 58118-2272-9, 58118-2272-3, 58118-2272-8, 58118-2272-0, 58118-2273-9, 58118-2273-3, 58118-2273-8, 58118-2273-0, 58118-2274-9, 58118-2274-3, 58118-2274-8, 58118-2274-0, 58118-2277-9, 58118-2277-3, 58118-2277-8, 58118-2277-0, 58118-2279-9, 58118-2279-3, 58118-2279-8, 58118-2279-0
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amlodipine Besylate and Benazepril Hydrochlorideamlodipine 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(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE2.5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
GELATIN(UNII: 2G86QN327L)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white with 2 gold bands) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;SANDOZ;571
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-2271-990 in 1 BOTTLE, PLASTIC
2NDC:58118-2271-330 in 1 BOTTLE, PLASTIC
3NDC:58118-2271-830 in 1 BLISTER PACK
4NDC:58118-2271-01 in 1 PACKET
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 Hydrochlorideamlodipine 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(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CROSPOVIDONE(UNII: 68401960MK)
GELATIN(UNII: 2G86QN327L)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BROWN (light brown with 2 white bands) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;SANDOZ;572
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-2272-990 in 1 BOTTLE, PLASTIC
2NDC:58118-2272-330 in 1 BOTTLE, PLASTIC
3NDC:58118-2272-830 in 1 BLISTER PACK
4NDC:58118-2272-01 in 1 PACKET
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 Hydrochlorideamlodipine 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(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
GELATIN(UNII: 2G86QN327L)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color PINK (pink with 2 white bands) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;SANDOZ;573
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-2273-990 in 1 BOTTLE, PLASTIC
2NDC:58118-2273-330 in 1 BOTTLE, PLASTIC
3NDC:58118-2273-830 in 1 BLISTER PACK
4NDC:58118-2273-01 in 1 PACKET
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 Hydrochlorideamlodipine 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(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CROSPOVIDONE(UNII: 68401960MK)
GELATIN(UNII: 2G86QN327L)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PURPLE (purple with 2 white bands) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;SANDOZ;574
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-2274-990 in 1 BOTTLE, PLASTIC
2NDC:58118-2274-330 in 1 BOTTLE, PLASTIC
3NDC:58118-2274-830 in 1 BLISTER PACK
4NDC:58118-2274-01 in 1 PACKET
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 Hydrochlorideamlodipine 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(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
GELATIN(UNII: 2G86QN327L)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE (light blue with 2 white bands) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;SANDOZ;577
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-2277-990 in 1 BOTTLE, PLASTIC
2NDC:58118-2277-330 in 1 BOTTLE, PLASTIC
3NDC:58118-2277-830 in 1 BLISTER PACK
4NDC:58118-2277-01 in 1 PACKET
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 Hydrochlorideamlodipine 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(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CROSPOVIDONE(UNII: 68401960MK)
GELATIN(UNII: 2G86QN327L)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (dark blue with 2 white bands) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;SANDOZ;578
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-2279-990 in 1 BOTTLE, PLASTIC
2NDC:58118-2279-330 in 1 BOTTLE, PLASTIC
3NDC:58118-2279-830 in 1 BLISTER PACK
4NDC:58118-2279-01 in 1 PACKET
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 Business Operations
Clinical Solutions Wholesale 078710347 repack(58118-2271, 58118-2272, 58118-2273, 58118-2274, 58118-2277, 58118-2279), relabel(58118-2271, 58118-2272, 58118-2273, 58118-2274, 58118-2277, 58118-2279)

PRINCIPAL DISPLAY PANEL

Package Label – 2.5 mg/ 10 mg

Package Label – 2.5 mg/ 10 mg

Package Label – 2.5 mg/ 10 mg

Package Label – 2.5 mg/ 10 mg

PRINCIPAL DISPLAY PANEL

Package Label – 5 mg/ 10 mg

Package Label – 5 mg/ 10 mg

Package Label – 5 mg/ 10 mg

Package Label – 5 mg/ 10 mg

PRINCIPAL DISPLAY PANEL

Package Label – 5 mg/ 20 mg

Package Label – 5 mg/ 20 mg

Package Label – 5 mg/ 20 mg

Package Label – 5 mg/ 20 mg

PRINCIPAL DISPLAY PANEL

Package Label – 5 mg/ 40 mg

Package Label – 5 mg/ 40 mg

Package Label – 5 mg/ 40 mg

Package Label – 5 mg/ 40 mg

PRINCIPAL DISPLAY PANEL

Package Label – 10 mg/ 20 mg

Package Label – 10 mg/ 20 mg

Package Label – 10 mg/ 20 mg

Package Label – 10 mg/ 20 mg

PRINCIPAL DISPLAY PANEL

Package Label – 10 mg/ 40 mg

Package Label – 10 mg/ 40 mg

Package Label – 10 mg/ 40 mg

Package Label – 10 mg/ 40 mg