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United States · US · US:71205-712_a0d22635-0e11-448d-b151-6f6168c65723

Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7120571210
    10 TABLET, FILM COATED in 1 BOTTLE (71205-712-10)
  • ndc11
    7120571214
    14 TABLET, FILM COATED in 1 BOTTLE (71205-712-14)
  • ndc11
    7120571220
    20 TABLET, FILM COATED in 1 BOTTLE (71205-712-20)
  • ndc11
    7120571221
    21 TABLET, FILM COATED in 1 BOTTLE (71205-712-21)
  • ndc11
    7120571228
    28 TABLET, FILM COATED in 1 BOTTLE (71205-712-28)
  • ndc11
    7120571230
    30 TABLET, FILM COATED in 1 BOTTLE (71205-712-30)
  • ndc11
    7120571260
    60 TABLET, FILM COATED in 1 BOTTLE (71205-712-60)
  • ndc11
    7120571290
    90 TABLET, FILM COATED in 1 BOTTLE (71205-712-90)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A065063
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": "71205-712_a0d22635-0e11-448d-b151-6f6168c65723",
  "productndc": "71205-712",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065063",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "875MG;EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Mar 14, 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": "ANDA065063",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20200501",
  "active_numerator_strength": "875; 125"
}

Related drugs

Other records sharing ATC code J01CA.

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