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United States · US · US:65862-068_6397ff45-3c37-40c3-a924-d036bb896b3b
Cefprozil
Orange BookUNIISPLATC J01DC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01DC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116586206801100 TABLET, FILM COATED in 1 BOTTLE (65862-068-01)
- ndc116586206805500 TABLET, FILM COATED in 1 BOTTLE (65862-068-05)
- ndc11658620683030 TABLET, FILM COATED in 1 BOTTLE (65862-068-30)
- ndc11658620685050 TABLET, FILM COATED in 1 BOTTLE (65862-068-50)
Annotations
UNII (FDA Substance ID)
4W0459ZA4V
CEFPROZIL
RxCUI 19552
Orange Book
A065340
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4W0459ZA4V",
"rxcui": "19552",
"inchikey": null,
"display_name": "CEFPROZIL",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"800a2ec0-4798-4423-9613-d03024cf1f0e": {
"match": "brand_token",
"title": "CEFPROZIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-05-06"
}
},
"productid": "65862-068_6397ff45-3c37-40c3-a924-d036bb896b3b",
"productndc": "65862-068",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "065340",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "May 24, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "May 24, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFPROZIL",
"proprietary_name": "Cefprozil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065340",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefprozil",
"start_marketing_date": "20070524",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01DC.
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