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United States · US · US:0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a

Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

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

Identification

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

Packs · 2

  • ndc11
    0781194339
    40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39)
  • ndc11
    0781194382
    28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A090227
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": "0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a",
  "productndc": "0781-1943",
  "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090227",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM;EQ 62.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 21, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM",
  "proprietary_name": "Amoxicillin and Clavulanate Potassium",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA090227",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20100421",
  "active_numerator_strength": "562.5; 437.5; 62.5"
}

Related drugs

Other records sharing ATC code J01CA.

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