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United States · US · US:71297-240_18975386-c292-a0cb-e063-6294a90aed18

Augmentin

Orange BookUNIISPLATC J01CA

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

Identification

ManufacturerAllegis Holdings, LLC
CountryUS (United States)
ATC codeJ01CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7129724034
    75 mL in 1 BOTTLE (71297-240-34)
  • ndc11
    7129724035
    100 mL in 1 BOTTLE (71297-240-35)
  • ndc11
    7129724036
    150 mL in 1 BOTTLE (71297-240-36)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
N050575
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": {
    "59979859-8c9b-4173-a5e3-2e6312fd9d79": {
      "match": "brand_token",
      "title": "AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR SUSPENSION [USANTIBIOTICS, LLC\n]",
      "spl_version": "4",
      "published_date": "2025-01-13"
    }
  },
  "productid": "71297-240_18975386-c292-a0cb-e063-6294a90aed18",
  "productndc": "71297-240",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "050575",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "125MG/5ML;EQ 31.25MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Aug 6, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG/5ML;EQ 62.5MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Aug 6, 1984"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
  "proprietary_name": "Augmentin",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "NDA050575",
  "marketing_category": "NDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20230901",
  "active_numerator_strength": "125; 31.25"
}

Related drugs

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