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United States · US · US:73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb

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
    7304300901
    50 mL in 1 BOTTLE (73043-009-01)
  • ndc11
    7304300902
    75 mL in 1 BOTTLE (73043-009-02)
  • ndc11
    7304300903
    100 mL in 1 BOTTLE (73043-009-03)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A210416
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": "73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb",
  "productndc": "73043-009",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "210416",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG/5ML;EQ 57MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Dec 11, 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": "ANDA210416",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20241101",
  "active_numerator_strength": "400; 57"
}

Related drugs

Other records sharing ATC code J01CA.

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