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 875 mg/1, clavulanate potassium 125 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-767
Product ID 55289-767_419b4e87-cb8b-8fbc-e063-6394a90a3b7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065096
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 55289767
Hyphenated Format 55289-767

Supplemental Identifiers

RxCUI
562508
UPC
0355289767305
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 ANDA065096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-21)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-30)
source: ndc

Packages (6)

55289-767-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-10) 55289-767-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-14) 55289-767-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-20) 55289-767-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-21) 55289-767-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-28) 55289-767-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-30)

Ingredients (2)

amoxicillin (875 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": "419b4e87-cb8b-8fbc-e063-6394a90a3b7c", "openfda": {"upc": ["0355289767305"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["e340b67b-332e-4e0c-aebf-ad4872dc5ed4"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-10)", "package_ndc": "55289-767-10", "marketing_start_date": "20110125"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-14)", "package_ndc": "55289-767-14", "marketing_start_date": "20110125"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-20)", "package_ndc": "55289-767-20", "marketing_start_date": "20110125"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-21)", "package_ndc": "55289-767-21", "marketing_start_date": "20110125"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-28)", "package_ndc": "55289-767-28", "marketing_start_date": "20110125"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-30)", "package_ndc": "55289-767-30", "marketing_start_date": "20110125"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "55289-767_419b4e87-cb8b-8fbc-e063-6394a90a3b7c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "55289-767", "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": "875 mg/1"}, {"name": "CLAVULANATE POTASSIUM", "strength": "125 mg/1"}], "application_number": "ANDA065096", "marketing_category": "ANDA", "marketing_start_date": "20021031", "listing_expiration_date": "20261231"}