United States· US:82868-002_483362cb-ea0d-7188-e063-6394a90abe59

AMOXICILLIN AND CLAVULANATE POTASSIUM

A penicillins with extended spectrum product containing amoxicillin and clavulanate potassium, registered in United States by Northwind Health Company, LLC.

ATC J01CAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Amoxicillin and Clavulanate Potassium
Manufacturer: Northwind Health Company, LLC
Country: United States (US)
ATC code: J01CA
ATC class: Penicillins with extended spectrum
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 2

ndc11
8286800210
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-10)
ndc11
8286800214
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-14)

Regulatory notes

UNII (FDA substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A204755

DailyMed SPL labels

1 version tracked

Same class

Other records under J01CA

Penicillins with extended spectrum, as other registers publish it.

All amoxicillin and clavulanate potassium products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/07a717fa-346f-4a26-a1dd-3331ed86d2c9
GET /v1/drugs/07a717fa-346f-4a26-a1dd-3331ed86d2c9?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "82868-002_483362cb-ea0d-7188-e063-6394a90abe59",
  "productndc": "82868-002",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204755",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "875MG;EQ 125MG BASE",
        "product_no": "003",
        "approval_date": "Dec 30, 2016"
      }
    ],
    "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": "ANDA204755",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20230926",
  "active_numerator_strength": "875; 125"
}

API reference MCP server Plans

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This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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