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United States · US · US:81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd

AUGMENTIN ES-600

Orange BookUNIISPLATC J01CA

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

Identification

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

Packs · 3

  • ndc11
    8196400351
    75 mL in 1 BOTTLE (81964-003-51)
  • ndc11
    8196400354
    200 mL in 1 BOTTLE (81964-003-54)
  • ndc11
    8196400369
    125 mL in 1 BOTTLE (81964-003-69)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
N050755
AB
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": "81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd",
  "productndc": "81964-003",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "050755",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "600MG/5ML;EQ 42.9MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Jun 22, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
  "proprietary_name": "AUGMENTIN ES-600",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "NDA050755",
  "marketing_category": "NDA",
  "nonproprietary_name": "amoxicillin and clavulanate potassium",
  "start_marketing_date": "20220715",
  "active_numerator_strength": "600; 42.9"
}

Related drugs

Other records sharing ATC code J01CA.

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