Cefaclor

Orange BookUNIISPLATC J01DC04

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

Identification

ManufacturerAzorian Pharma, LLC

CountryUS (United States)

ATC codeJ01DC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8194862501
150 mL in 1 BOTTLE (81948-6250-1)

Annotations

UNII (FDA Substance ID)

69K7K19H4L

CEFACLOR

RxCUI 2176

Orange Book

A065412

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": "81948-6250_a6a7fcf7-b9dc-4dac-b127-418588586a8a",
  "productndc": "81948-6250",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "065412",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 125MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Feb 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 187MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Feb 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 250MG BASE/5ML",
        "product_no": "003",
        "approval_date": "Feb 17, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 375MG BASE/5ML",
        "product_no": "004",
        "approval_date": "Feb 17, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFACLOR",
  "proprietary_name": "Cefaclor",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065412",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cefaclor",
  "start_marketing_date": "20221101",
  "active_numerator_strength": "250"
}

Related drugs

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