Amoxicillin

Orange BookUNIISPLATC J01CA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeJ01CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009004550
30 TABLET, CHEWABLE in 1 BOTTLE (50090-0455-0)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A064013

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": "50090-0455_845fc154-9902-4853-9aac-81a2d9c11799",
  "productndc": "50090-0455",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "064013",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Dec 22, 1992"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "125MG",
        "product_no": "002",
        "approval_date": "Sep 11, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN",
  "proprietary_name": "Amoxicillin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA064013",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "19930101",
  "active_numerator_strength": "250"
}

Related drugs

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