Amoxicillin

Orange BookUNIISPLATC J01CA04

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ01CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6318772914
14 TABLET, FILM COATED in 1 BOTTLE (63187-729-14)
ndc11
6318772920
20 TABLET, FILM COATED in 1 BOTTLE (63187-729-20)
ndc11
6318772921
21 TABLET, FILM COATED in 1 BOTTLE (63187-729-21)
ndc11
6318772928
28 TABLET, FILM COATED in 1 BOTTLE (63187-729-28)
ndc11
6318772930
30 TABLET, FILM COATED in 1 BOTTLE (63187-729-30)
ndc11
6318772940
40 TABLET, FILM COATED in 1 BOTTLE (63187-729-40)

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": "63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec",
  "productndc": "63187-729",
  "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": "20051109",
  "active_numerator_strength": "875"
}

Related drugs

Other records sharing ATC code J01CA04.

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