Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeJ01CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6878883181
100 mL in 1 BOTTLE (68788-8318-1)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A201090

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": "68788-8318_2c966f10-3845-4fa9-aa1f-c56e7a671252",
  "productndc": "68788-8318",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "201090",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/5ML;EQ 28.5MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Dec 20, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG/5ML;EQ 57MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Dec 20, 2011"
      }
    ],
    "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": "ANDA201090",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20221223",
  "active_numerator_strength": "400; 57"
}

Related drugs

Other records sharing ATC code J01CA.

Access this data programmatically

Query Amoxicillin and Clavulanate Potassium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs