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United States · US · US:55289-767_419b4e87-cb8b-8fbc-e063-6394a90a3b7c

Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

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

Identification

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

Packs · 6

  • ndc11
    5528976710
    10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-10)
  • ndc11
    5528976714
    14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-14)
  • ndc11
    5528976720
    20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-20)
  • ndc11
    5528976721
    21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-21)
  • ndc11
    5528976728
    28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-28)
  • ndc11
    5528976730
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-30)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A065096
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": "55289-767_419b4e87-cb8b-8fbc-e063-6394a90a3b7c",
  "productndc": "55289-767",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065096",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "875MG;EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Oct 29, 2002"
      }
    ],
    "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/1; mg/1",
  "application_number": "ANDA065096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20021031",
  "active_numerator_strength": "875; 125"
}

Related drugs

Other records sharing ATC code J01CA.

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