Back to search
🇺🇸

United States · US · US:0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37ecc

Cefaclor

Orange BookUNIISPLATC J01DC04

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

Identification

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

Packs · 1

  • ndc11
    0093108701
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)

Annotations

UNII (FDA Substance ID)
69K7K19H4L
CEFACLOR
RxCUI 2176
Orange Book
A065058
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": "0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37ecc",
  "productndc": "0093-1087",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "065058",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 375MG BASE",
        "product_no": "001",
        "approval_date": "Sep 4, 2002"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Sep 4, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFACLOR",
  "proprietary_name": "Cefaclor",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065058",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefaclor",
  "start_marketing_date": "20020926",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01DC04.

Access this data programmatically

Query Cefaclor and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.