amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: medsource pharmaceuticals
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 medsource pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amoxicillin 500 mg/1, clavulanate potassium 125 mg/1

Manufacturer
Medsource Pharmaceuticals

Identifiers & Regulatory

Product NDC 45865-230
Product ID 45865-230_1275ba9e-689e-104c-e063-6394a90a2b15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205707
Listing Expiration 2026-12-31
Marketing Start 2017-03-01

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 45865230
Hyphenated Format 45865-230

Supplemental Identifiers

RxCUI
617296
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 ANDA205707 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (45865-230-20)
source: ndc

Packages (1)

45865-230-20 20 TABLET, FILM COATED in 1 BOTTLE (45865-230-20)

Ingredients (2)

amoxicillin (500 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": "1275ba9e-689e-104c-e063-6394a90a2b15", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617296"], "spl_set_id": ["1275ad58-c53f-20d0-e063-6394a90a4a43"], "manufacturer_name": ["Medsource Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (45865-230-20)", "package_ndc": "45865-230-20", "marketing_start_date": "20231130"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "45865-230_1275ba9e-689e-104c-e063-6394a90a2b15", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "45865-230", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Medsource Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate Potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "500 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA205707", "marketing_category": "ANDA", "marketing_start_date": "20170301", "listing_expiration_date": "20261231"}