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 · 7

ndc11
7120581714
14 CAPSULE in 1 BOTTLE (71205-817-14)
ndc11
7120581720
20 CAPSULE in 1 BOTTLE (71205-817-20)
ndc11
7120581721
21 CAPSULE in 1 BOTTLE (71205-817-21)
ndc11
7120581730
30 CAPSULE in 1 BOTTLE (71205-817-30)
ndc11
7120581740
40 CAPSULE in 1 BOTTLE (71205-817-40)
ndc11
7120581760
60 CAPSULE in 1 BOTTLE (71205-817-60)
ndc11
7120581790
90 CAPSULE in 1 BOTTLE (71205-817-90)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A065271

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": "71205-817_2c395111-c9c1-483e-a542-58b935ede689",
  "productndc": "71205-817",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065271",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Nov 9, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "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": "ANDA065271",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "20051109",
  "active_numerator_strength": "500"
}

Related drugs

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