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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
- ndc110093108701100 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
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- 🇺🇸CefaclorCarlsbad Technology, Inc.
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