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United States · US · US:61442-171_3417e20b-604b-3cdd-e063-6394a90ac707

Cefaclor

Orange BookUNIISPLATC J01DC04

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

Identification

ManufacturerCarlsbad Technology, Inc.
CountryUS (United States)
ATC codeJ01DC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6144217101
    100 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-01)
  • ndc11
    6144217105
    500 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-05)
  • ndc11
    6144217130
    30 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-30)

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": "61442-171_3417e20b-604b-3cdd-e063-6394a90ac707",
  "productndc": "61442-171",
  "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": "250"
}

Related drugs

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