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United States · US · US:70518-3580_4f5b7578-a0ce-82db-e063-6394a90a8426

Cefadroxil

Orange BookUNIISPLATC J01DB05

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01DB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7051835800
    20 CAPSULE in 1 BLISTER PACK (70518-3580-0)
  • ndc11
    7051835801
    30 CAPSULE in 1 BLISTER PACK (70518-3580-1)

Annotations

UNII (FDA Substance ID)
280111G160
CEFADROXIL
RxCUI 204175
Orange Book
A065392
AB
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": "70518-3580_4f5b7578-a0ce-82db-e063-6394a90a8426",
  "productndc": "70518-3580",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065392",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "001",
        "approval_date": "May 29, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFADROXIL",
  "proprietary_name": "Cefadroxil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065392",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefadroxil",
  "start_marketing_date": "20221122",
  "active_numerator_strength": "500"
}

Related drugs

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