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United States· US:42571-162_3a71d6d7-6111-a0f8-e063-6394a90aa0e7

AMOXICILLIN AND CLAVULANATE POTASSIUM

A penicillins with extended spectrum product containing amoxicillin and clavulanate potassium, registered in United States by Micro Labs Limited.

ATC J01CAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAMOXICILLIN AND CLAVULANATE POTASSIUMATCJ01CAREGISTER NO.US:42571-162_3a71d6d7…PACKS LISTED3CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about amoxicillin and clavulanate potassiumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Amoxicillin and Clavulanate Potassium
Manufacturer
Micro Labs Limited
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 · 3

  • ndc11
    4257116201
    100 TABLET, FILM COATED in 1 BOTTLE (42571-162-01)
  • ndc11
    4257116242
    20 TABLET, FILM COATED in 1 BOTTLE (42571-162-42)
  • ndc11
    4257116244
    4 BLISTER PACK in 1 CARTON (42571-162-44) / 4 TABLET, FILM COATED in 1 BLISTER PACK (42571-162-43)

Regulatory notes

UNII (FDA substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A204755
AB
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/dc0f4f28-0eff-44d8-8e1d-7cf81c767689
GET /v1/drugs/dc0f4f28-0eff-44d8-8e1d-7cf81c767689?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": "42571-162_3a71d6d7-6111-a0f8-e063-6394a90aa0e7",
  "productndc": "42571-162",
  "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": "20170301",
  "active_numerator_strength": "875; 125"
}
API referenceMCP serverPlans

See everything about amoxicillin and clavulanate potassium.

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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