amoxicillin and clavulanate potassium (50090-4413)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler a-s medication solutions

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amoxicillin 875 mg/1, clavulanate potassium 125 mg/1

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4413

Product ID 50090-4413_048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091568

Listing Expiration 2026-12-31

Marketing Start 2012-01-20

Pharmacologic Class

Classes

penicillin-class antibacterial [epc] penicillins [cs] beta lactamase inhibitor [epc] beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904413

Hyphenated Format 50090-4413

Supplemental Identifiers

RxCUI

562508

UNII

804826J2HU Q42OMW3AT8

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amoxicillin and clavulanate potassium (source: ndc)

Generic Name amoxicillin and clavulanate potassium (source: ndc)

Application Number ANDA091568 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

875 mg/1
125 mg/1

source: ndc

Packaging

48 BOTTLE in 1 CASE (50090-4413-0) / 20 TABLET, FILM COATED in 1 BOTTLE
24 BOTTLE in 1 CASE (50090-4413-1) / 20 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (2)

50090-4413-0 48 BOTTLE in 1 CASE (50090-4413-0) / 20 TABLET, FILM COATED in 1 BOTTLE 50090-4413-1 24 BOTTLE in 1 CASE (50090-4413-1) / 20 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

amoxicillin (875 mg/1) clavulanate potassium (125 mg/1)

Linked Drug Pages (1)

Amoxicillin and Clavulanate Potassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "48 BOTTLE in 1 CASE (50090-4413-0)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50090-4413-0", "marketing_start_date": "20190716"}, {"sample": false, "description": "24 BOTTLE in 1 CASE (50090-4413-1)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50090-4413-1", "marketing_start_date": "20240214"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "50090-4413_048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "50090-4413", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "875 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA091568", "marketing_category": "ANDA", "marketing_start_date": "20120120", "listing_expiration_date": "20261231"}