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United States · US · US:16714-295_ef0e5a65-a3fc-41b2-8e60-f8d056c972dd

Amoxicillin and Clavulanate Potassium

Orange BookUNIISPLATC J01CA

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

Identification

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

Packs · 1

  • ndc11
    1671429501
    30 TABLET, FILM COATED in 1 BOTTLE (16714-295-01)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A091569
ABAB
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": "16714-295_ef0e5a65-a3fc-41b2-8e60-f8d056c972dd",
  "productndc": "16714-295",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091569",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG;EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Jan 20, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 125MG BASE",
        "product_no": "002",
        "approval_date": "Jan 20, 2012"
      }
    ],
    "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": "ANDA091569",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
  "start_marketing_date": "20120120",
  "active_numerator_strength": "250; 125"
}

Related drugs

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