amoxicillin and clavulanate potassium (59651-026)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler aurobindo pharma limited

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL

Active Ingredients

amoxicillin 250 mg/5mL, clavulanate potassium 62.5 mg/5mL

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-026

Product ID 59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209371

Listing Expiration 2026-12-31

Marketing Start 2019-04-19

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 59651026

Hyphenated Format 59651-026

Supplemental Identifiers

RxCUI

617302 617322

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 ANDA209371 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/5mL
62.5 mg/5mL

source: ndc

Packaging

100 mL in 1 BOTTLE (59651-026-01)
150 mL in 1 BOTTLE (59651-026-55)
75 mL in 1 BOTTLE (59651-026-75)

source: ndc

Packages (3)

59651-026-01 100 mL in 1 BOTTLE (59651-026-01) 59651-026-55 150 mL in 1 BOTTLE (59651-026-55) 59651-026-75 75 mL in 1 BOTTLE (59651-026-75)

Ingredients (2)

amoxicillin (250 mg/5mL) clavulanate potassium (62.5 mg/5mL)

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": "8c4f5611-f65b-42c2-8412-e616f149ee90", "openfda": {"unii": ["Q42OMW3AT8", "804826J2HU"], "rxcui": ["617302", "617322"], "spl_set_id": ["3ae0c95f-7ffa-4317-9fea-4d07b86bee72"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (59651-026-01)", "package_ndc": "59651-026-01", "marketing_start_date": "20190419"}, {"sample": false, "description": "150 mL in 1 BOTTLE (59651-026-55)", "package_ndc": "59651-026-55", "marketing_start_date": "20190419"}, {"sample": false, "description": "75 mL in 1 BOTTLE (59651-026-75)", "package_ndc": "59651-026-75", "marketing_start_date": "20190419"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "59651-026", "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/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "62.5 mg/5mL"}], "application_number": "ANDA209371", "marketing_category": "ANDA", "marketing_start_date": "20190419", "listing_expiration_date": "20261231"}