Amoxicillin and Clavulanate Potassium

{
  "unii": {
    "unii": "804826J2HU",
    "rxcui": "133008",
    "inchikey": "MQXQVCLAUDMCEF-CWLIKTDRSA-N",
    "display_name": "AMOXICILLIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "263a2902-f85c-46b6-8d5b-8c99f5c4b706": {
      "match": "brand_token",
      "title": "AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "81964-220_45c6020c-fd42-d920-e063-6294a90a67e0",
  "productndc": "81964-220",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "050785",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Sep 25, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM",
  "proprietary_name": "Amoxicillin and Clavulanate Potassium",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA050785",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "amoxicillin and clavulanate potassium",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "562.5; 437.5; 62.5"
}