Amoxicillin

Orange BookUNIISPLATC J01CA04

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeJ01CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7051821911
30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-1)
ndc11
7051821912
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2191-2)
ndc11
7051821913
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2191-3)
ndc11
7051821914
14 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-4)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A065256

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": "70518-2191_49dbf57d-96d4-d3d6-e063-6394a90ac2d3",
  "productndc": "70518-2191",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065256",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Nov 9, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "875MG",
        "product_no": "002",
        "approval_date": "Nov 9, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN",
  "proprietary_name": "Amoxicillin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065256",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "20190709",
  "active_numerator_strength": "875"
}

Related drugs

Other records sharing ATC code J01CA04.

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