Amoxicillin

These highlights do not include all the information needed to use AMOXICILLIN Capsules and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules and for Oral Suspension, USP. AMOXICILLIN Capsules and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974

Approved

Approval ID

7f813093-98a2-452a-b6f1-132fe40f76c7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 11, 2016

Manufacturers

FDA

Blenheim Pharmacal, Inc

DUNS: 171434587

Products 2

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

Amoxicillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10544-958

Application NumberANDA064076

Product Classification

Marketing Category

C73584

Generic Name

Amoxicillin

Product Specifications

Route of AdministrationORAL

Effective DateMay 11, 2016

FDA Product Classification

INGREDIENTS (15)

AMOXICILLINActive

Quantity: 500 mg in 1 1

Code: 804826J2HU

Classification: ACTIM

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Amoxicillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10544-959

Application NumberANDA064076

Product Classification

Marketing Category

C73584

Generic Name

Amoxicillin

Product Specifications

Route of AdministrationORAL

Effective DateMay 11, 2016

FDA Product Classification

INGREDIENTS (15)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

AMOXICILLINActive

Quantity: 250 mg in 1 1

Code: 804826J2HU

Classification: ACTIM

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Amoxicillin

Products 2

Amoxicillin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Amoxicillin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

MedPath

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Company

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