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": "81964-212_3854c6ad-10f7-dae3-e063-6294a90ae00a",
  "productndc": "81964-212",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "050575",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "125MG/5ML;EQ 31.25MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Aug 6, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG/5ML;EQ 62.5MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Aug 6, 1984"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
  "proprietary_name": "AMOXICILLIN AND CLAVULANATE POTASSIUM",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "NDA050575",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20221205",
  "active_numerator_strength": "125; 31.25"
}