amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 125 mg/5mL, clavulanate potassium 31.25 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-025
Product ID 59651-025_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 59651025
Hyphenated Format 59651-025

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
  • 125 mg/5mL
  • 31.25 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (59651-025-01)
  • 150 mL in 1 BOTTLE (59651-025-55)
  • 75 mL in 1 BOTTLE (59651-025-75)
source: ndc

Packages (3)

59651-025-01 100 mL in 1 BOTTLE (59651-025-01) 59651-025-55 150 mL in 1 BOTTLE (59651-025-55) 59651-025-75 75 mL in 1 BOTTLE (59651-025-75)

Ingredients (2)

amoxicillin (125 mg/5mL) clavulanate potassium (31.25 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 (59651-025-01)", "package_ndc": "59651-025-01", "marketing_start_date": "20190419"}, {"sample": false, "description": "150 mL in 1 BOTTLE (59651-025-55)", "package_ndc": "59651-025-55", "marketing_start_date": "20190419"}, {"sample": false, "description": "75 mL in 1 BOTTLE (59651-025-75)", "package_ndc": "59651-025-75", "marketing_start_date": "20190419"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "59651-025_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": "59651-025", "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": "125 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "31.25 mg/5mL"}], "application_number": "ANDA209371", "marketing_category": "ANDA", "marketing_start_date": "20190419", "listing_expiration_date": "20261231"}