Cefadroxil

Orange BookUNIISPLATC J01DB05

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

Identification

ManufacturerNorthStar Rx LLC

CountryUS (United States)

ATC codeJ01DB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1671438901
100 mL in 1 BOTTLE (16714-389-01)

Annotations

UNII (FDA Substance ID)

280111G160

CEFADROXIL

RxCUI 204175

Orange Book

A065349

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "280111G160",
    "rxcui": "204175",
    "inchikey": "NBFNMSULHIODTC-CYJZLJNKSA-N",
    "display_name": "CEFADROXIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4fb524c1-f985-2a8f-e063-6394a90aab7f": {
      "match": "brand_token",
      "title": "CEFADROXIL CAPSULE [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-04-20"
    }
  },
  "productid": "16714-389_323b9a4d-c8fc-4fdb-bba4-834468a0a770",
  "productndc": "16714-389",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065349",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Apr 25, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Apr 25, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFADROXIL",
  "proprietary_name": "Cefadroxil",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065349",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefadroxil",
  "start_marketing_date": "20130425",
  "active_numerator_strength": "250"
}

Related drugs

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