Amoxicillin

Orange BookUNIISPLATC J01CA04

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

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
7642081901
100 mL in 1 BOTTLE (76420-819-01)
ndc11
7642081950
50 mL in 1 BOTTLE (76420-819-50)
ndc11
7642081975
75 mL in 1 BOTTLE (76420-819-75)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A065378

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": "76420-819_1bc435f9-12b8-ccff-e063-6294a90a951a",
  "productndc": "76420-819",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065378",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG/5ML",
        "product_no": "002",
        "approval_date": "Mar 26, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN",
  "proprietary_name": "Amoxicillin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065378",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "20070326",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01CA04.

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