Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeJ01CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A065063

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": "50090-6530_5b50becc-70fc-4266-ba5b-bc0770ad5fb5",
  "productndc": "50090-6530",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065063",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "875MG;EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Mar 14, 2002"
      }
    ],
    "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": "ANDA065063",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20200501",
  "active_numerator_strength": "875; 125"
}

Related drugs

Other records sharing ATC code J01CA.

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