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 43063-077
Product ID 43063-077_413731a6-a006-1bb0-e063-6294a90ac8eb
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 43063077
Hyphenated Format 43063-077

Supplemental Identifiers

RxCUI
562508
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
  • 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-03)
  • 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-04)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-06)
source: ndc

Packages (3)

43063-077-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-03) 43063-077-04 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-04) 43063-077-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-06)

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": "413731a6-a006-1bb0-e063-6294a90ac8eb", "openfda": {"unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["562508"], "spl_set_id": ["b04330a0-2b8d-4cf9-a08e-19007d1001ad"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-03)", "package_ndc": "43063-077-03", "marketing_start_date": "20090226"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-04)", "package_ndc": "43063-077-04", "marketing_start_date": "20090226"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-06)", "package_ndc": "43063-077-06", "marketing_start_date": "20090226"}], "brand_name": "Amoxicillin and Clavulanate Potassium", "product_id": "43063-077_413731a6-a006-1bb0-e063-6294a90ac8eb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "43063-077", "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"}