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United States · US · US:42571-161_3a71d6d7-6111-a0f8-e063-6394a90aa0e7

AMOXICILLIN AND CLAVULANATE POTASSIUM

Orange BookUNIISPLATC J01CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeJ01CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4257116101
    100 TABLET, FILM COATED in 1 BOTTLE (42571-161-01)
  • ndc11
    4257116111
    10 BLISTER PACK in 1 CARTON (42571-161-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-161-32)
  • ndc11
    4257116142
    20 TABLET, FILM COATED in 1 BOTTLE (42571-161-42)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A205707
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": "42571-161_3a71d6d7-6111-a0f8-e063-6394a90aa0e7",
  "productndc": "42571-161",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205707",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG;EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Dec 30, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 125MG BASE",
        "product_no": "002",
        "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": "ANDA205707",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20170301",
  "active_numerator_strength": "500; 125"
}

Related drugs

Other records sharing ATC code J01CA.

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