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United States · US · US:62135-777_4690a5fd-79cc-e1fd-e063-6294a90a009c

AMOXICILLIN

Orange BookUNIISPLATC J01CA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeJ01CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6213577738
    150 mL in 1 BOTTLE (62135-777-38)
  • ndc11
    6213577742
    100 mL in 1 BOTTLE (62135-777-42)
  • ndc11
    6213577768
    80 mL in 1 BOTTLE (62135-777-68)

Annotations

UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A062059
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": "62135-777_4690a5fd-79cc-e1fd-e063-6294a90a009c",
  "productndc": "62135-777",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "062059",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "125MG/5ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG/5ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN",
  "proprietary_name": "AMOXICILLIN",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA062059",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amoxicillin",
  "start_marketing_date": "19781208",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01CA04.

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