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United States · US · US:57237-097_59b4c983-458c-4363-b2e6-4253a2bc7992

Cefadroxil

Orange BookUNIISPLATC J01DB05

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeJ01DB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5723709701
    100 mL in 1 BOTTLE (57237-097-01)
  • ndc11
    5723709750
    50 mL in 1 BOTTLE (57237-097-50)

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": "57237-097_59b4c983-458c-4363-b2e6-4253a2bc7992",
  "productndc": "57237-097",
  "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"
}

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