Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

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

Identification

ManufacturerMicro Labs Limited

CountryUS (United States)

ATC codeJ01CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4257116447
100 mL in 1 BOTTLE (42571-164-47)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A205187

ABAB

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": "42571-164_22ff093e-19eb-7dd4-e063-6394a90ac20d",
  "productndc": "42571-164",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "205187",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/5ML;EQ 28.5MG BASE/5ML",
        "product_no": "001",
        "approval_date": "May 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG/5ML;EQ 57MG BASE/5ML",
        "product_no": "002",
        "approval_date": "May 21, 2021"
      }
    ],
    "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/5mL; mg/5mL",
  "application_number": "ANDA205187",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20210701",
  "active_numerator_strength": "400; 57"
}

Related drugs

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