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United States · US · US:50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaa

Cefaclor

Orange BookUNIISPLATC J01DC04

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01DC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009016020
    30 CAPSULE in 1 BOTTLE (50090-1602-0)
  • ndc11
    5009016022
    21 CAPSULE in 1 BOTTLE (50090-1602-2)

Annotations

UNII (FDA Substance ID)
69K7K19H4L
CEFACLOR
RxCUI 2176
Orange Book
A065146
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "69K7K19H4L",
    "rxcui": "2176",
    "inchikey": "WKJGTOYAEQDNIA-IOOZKYRYSA-N",
    "display_name": "CEFACLOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2f61354e-bcb0-41aa-955f-51eabc11387b": {
      "match": "brand_token",
      "title": "CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.]",
      "spl_version": "4",
      "published_date": "2025-05-05"
    }
  },
  "productid": "50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaa",
  "productndc": "50090-1602",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065146",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Jan 22, 2004"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Jan 22, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFACLOR",
  "proprietary_name": "Cefaclor",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065146",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefaclor",
  "start_marketing_date": "20080731",
  "active_numerator_strength": "500"
}

Related drugs

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