Amoxil

Orange BookUNIISPLATC J01CA04

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

Identification

ManufacturerDirectRx

CountryUS (United States)

ATC codeJ01CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218938532
100 mL in 1 BOTTLE (72189-385-32)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A065325

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": {
    "ec7dd735-dc92-3d29-e053-2a95a90af549": {
      "match": "brand_token",
      "title": "AMOXIL (AMOXICILLIN ORAL SUSP) POWDER, FOR SUSPENSION [DIRECTRX]",
      "spl_version": "3",
      "published_date": "2025-01-23"
    }
  },
  "productid": "72189-385_2c4cbe6c-c27d-15fe-e063-6294a90ac409",
  "productndc": "72189-385",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065325",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG/5ML",
        "product_no": "001",
        "approval_date": "Jun 19, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/5ML",
        "product_no": "002",
        "approval_date": "Jun 19, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN",
  "proprietary_name": "Amoxil",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065325",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin Oral Susp",
  "start_marketing_date": "20221021",
  "active_numerator_strength": "400"
}

Related drugs

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