amoxicillin and clavulanate potassium (65862-501)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amoxicillin 250 mg/1, clavulanate potassium 125 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-501

Product ID 65862-501_2b91e9f8-c77e-4330-8fc1-e574758f0db6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091569

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 65862501

Hyphenated Format 65862-501

Supplemental Identifiers

RxCUI

562251 562508 617296

UNII

Q42OMW3AT8 804826J2HU

Packaging Origin

Original Packager

true

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 ANDA091569 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1
125 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED in 1 BOTTLE (65862-501-05)
30 TABLET, FILM COATED in 1 BOTTLE (65862-501-30)

source: ndc

Packages (2)

65862-501-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-501-05) 65862-501-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-501-30)

Ingredients (2)

amoxicillin (250 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": "2b91e9f8-c77e-4330-8fc1-e574758f0db6", "openfda": {"unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["562251", "562508", "617296"], "spl_set_id": ["ffb158a1-83ba-4100-9221-175aa986dc3e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-501-05)", "package_ndc": "65862-501-05", "marketing_start_date": "20120120"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-501-30)", "package_ndc": "65862-501-30", "marketing_start_date": "20120120"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "65862-501_2b91e9f8-c77e-4330-8fc1-e574758f0db6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "65862-501", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "250 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA091569", "marketing_category": "ANDA", "marketing_start_date": "20120120", "listing_expiration_date": "20261231"}