Amoxicillin

Orange BookUNIISPLATC J01CA04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ01CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0143988901
100 mL in 1 BOTTLE (0143-9889-01)
ndc11
0143988915
150 mL in 1 BOTTLE (0143-9889-15)
ndc11
0143988980
80 mL in 1 BOTTLE (0143-9889-80)

Annotations

UNII (FDA Substance ID)

804826J2HU

AMOXICILLIN

RxCUI 133008

Orange Book

A065322

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": "0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002",
  "productndc": "0143-9889",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065322",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML",
        "product_no": "001",
        "approval_date": "Jun 19, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG/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": "Amoxicillin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065322",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "20060619",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01CA04.

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