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United States · US · US:73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da

amoxicillin and clavulanate potassium

Orange BookUNIISPLATC J01CA

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

Identification

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

Packs · 3

  • ndc11
    7304301001
    75 mL in 1 BOTTLE (73043-010-01)
  • ndc11
    7304301002
    100 mL in 1 BOTTLE (73043-010-02)
  • ndc11
    7304301003
    150 mL in 1 BOTTLE (73043-010-03)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A210374
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": {
    "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": "73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da",
  "productndc": "73043-010",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "210374",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML;EQ 62.5MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Nov 29, 2023"
      }
    ],
    "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": "ANDA210374",
  "marketing_category": "ANDA",
  "nonproprietary_name": "amoxicillin and clavulanate potassium",
  "start_marketing_date": "20240705",
  "active_numerator_strength": "250; 62.5"
}

Related drugs

Other records sharing ATC code J01CA.

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