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United States · US · US:59651-025_8c4f5611-f65b-42c2-8412-e616f149ee90

Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

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

Identification

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

Packs · 3

  • ndc11
    5965102501
    100 mL in 1 BOTTLE (59651-025-01)
  • ndc11
    5965102555
    150 mL in 1 BOTTLE (59651-025-55)
  • ndc11
    5965102575
    75 mL in 1 BOTTLE (59651-025-75)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A209371
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": "59651-025_8c4f5611-f65b-42c2-8412-e616f149ee90",
  "productndc": "59651-025",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "209371",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG/5ML;EQ 31.25MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Apr 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML;EQ 62.5MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Apr 19, 2019"
      }
    ],
    "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/5mL; mg/5mL",
  "application_number": "ANDA209371",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20190419",
  "active_numerator_strength": "125; 31.25"
}

Related drugs

Other records sharing ATC code J01CA.

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