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AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN AND CLAVULANATE POTASSIUM tablet

Approved
Approval ID

61eaa530-43e1-4964-81ff-8e9ffaa7521c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 24, 2014

Manufacturers
FDA

Northwind Pharmaceuticals. LLC

DUNS: 036986393

Products 1

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

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51655-160
Application NumberANDA065096
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2014
FDA Product Classification

INGREDIENTS (2)

AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM

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AMOXICILLIN AND CLAVULANATE POTASSIUM - FDA Drug Approval Details