amoxicillin and clavulanate potassium

Generic: amoxicillin and clavulanate potassium

Labeler: pd-rx pharmaceuticals, inc.
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 pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-845
Product ID 55289-845_419b7d75-b6cc-e646-e063-6294a90a8d2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065101
Listing Expiration 2026-12-31
Marketing Start 2002-10-31

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 55289845
Hyphenated Format 55289-845

Supplemental Identifiers

RxCUI
617296
UPC
0355289845201
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 ANDA065101 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30)
source: ndc

Packages (5)

55289-845-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06) 55289-845-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20) 55289-845-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21) 55289-845-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28) 55289-845-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30)

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": "419b7d75-b6cc-e646-e063-6294a90a8d2e", "openfda": {"upc": ["0355289845201"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617296"], "spl_set_id": ["cc445a39-d84c-4b76-9fb8-ae302e7cd96b"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06)", "package_ndc": "55289-845-06", "marketing_start_date": "20121206"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20)", "package_ndc": "55289-845-20", "marketing_start_date": "20121206"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21)", "package_ndc": "55289-845-21", "marketing_start_date": "20121206"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28)", "package_ndc": "55289-845-28", "marketing_start_date": "20121206"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30)", "package_ndc": "55289-845-30", "marketing_start_date": "20121206"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "55289-845_419b7d75-b6cc-e646-e063-6294a90a8d2e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "55289-845", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "ANDA065101", "marketing_category": "ANDA", "marketing_start_date": "20021031", "listing_expiration_date": "20261231"}