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United States · US · US:85766-019_4a022ff2-b0e8-9063-e063-6294a90a8fbe

Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeJ01CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8576601901
    100 TABLET, FILM COATED in 1 BOTTLE (85766-019-01)
  • ndc11
    8576601920
    20 TABLET, FILM COATED in 1 BOTTLE (85766-019-20)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A091568
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "85766-019_4a022ff2-b0e8-9063-e063-6294a90a8fbe",
  "productndc": "85766-019",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091568",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "875MG;EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Jan 20, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
  "proprietary_name": "Amoxicillin and Clavulanate Potassium",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA091568",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20120120",
  "active_numerator_strength": "875; 125"
}

Related drugs

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