Lotrel

These highlights do not include all the information needed to use Lotrel safely and effectively. See full prescribing information for Lotrel. Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules Initial U.S. Approval: 1995

Approved

Approval ID

4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 2, 2012

Manufacturers

FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

amlodipine besylate and benazepril hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4870

Application NumberNDA020364

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and benazepril hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2012

FDA Product Classification

INGREDIENTS (17)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

BENAZEPRIL HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: N1SN99T69T

Classification: ACTIB

CALCIUM PHOSPHATEInactive

Code: 97Z1WI3NDX

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

amlodipine besylate and benazepril hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5783

Application NumberNDA020364

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and benazepril hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2012

FDA Product Classification

INGREDIENTS (16)

BENAZEPRIL HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: N1SN99T69T

Classification: ACTIB

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM PHOSPHATEInactive

Code: 97Z1WI3NDX

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

amlodipine besylate and benazepril hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5690

Application NumberNDA020364

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and benazepril hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2012

FDA Product Classification

INGREDIENTS (16)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM PHOSPHATEInactive

Code: 97Z1WI3NDX

Classification: IACT

BENAZEPRIL HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: N1SN99T69T

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

amlodipine besylate and benazepril hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4074

Application NumberNDA020364

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and benazepril hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2012

FDA Product Classification

INGREDIENTS (17)

CALCIUM PHOSPHATEInactive

Code: 97Z1WI3NDX

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

BENAZEPRIL HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: N1SN99T69T

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

amlodipine besylate and benazepril hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4073

Application NumberNDA020364

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and benazepril hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2012

FDA Product Classification

INGREDIENTS (17)

BENAZEPRIL HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: N1SN99T69T

Classification: ACTIB

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM PHOSPHATEInactive

Code: 97Z1WI3NDX

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

amlodipine besylate and benazepril hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4066

Application NumberNDA020364

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and benazepril hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2012

FDA Product Classification

INGREDIENTS (17)

AMLODIPINE BESYLATEActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

BENAZEPRIL HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: N1SN99T69T

Classification: ACTIB

CALCIUM PHOSPHATEInactive

Code: 97Z1WI3NDX

Classification: IACT

CROSPOVIDONEInactive

Code: 68401960MK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

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Lotrel

Products 6

amlodipine besylate and benazepril hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

amlodipine besylate and benazepril hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

amlodipine besylate and benazepril hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

amlodipine besylate and benazepril hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

amlodipine besylate and benazepril hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

amlodipine besylate and benazepril hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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