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United States · US · US:87063-058_45973812-ad2c-0c60-e063-6394a90a9ddc

Amoxicillin

Orange BookUNIISPLATC J01CA04

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

Identification

ManufacturerASCLEMED USA INC.
CountryUS (United States)
ATC codeJ01CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8706305801
    100 mL in 1 BOTTLE (87063-058-01)
  • ndc11
    8706305850
    50 mL in 1 BOTTLE (87063-058-50)
  • ndc11
    8706305875
    75 mL in 1 BOTTLE (87063-058-75)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
N050760
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": "87063-058_45973812-ad2c-0c60-e063-6394a90a9ddc",
  "productndc": "87063-058",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "050760",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Apr 15, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Apr 15, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN",
  "proprietary_name": "Amoxicillin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA050760",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "20240401",
  "active_numerator_strength": "400"
}

Related drugs

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