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United States · US · US:0093-1078_c226712f-00c2-407f-8b40-5ed1be54dfb8
Cefprozil
Orange BookUNIISPLATC J01DC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01DC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11009310785350 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53)
Annotations
UNII (FDA Substance ID)
4W0459ZA4V
CEFPROZIL
RxCUI 19552
Orange Book
A065208
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": "0093-1078_c226712f-00c2-407f-8b40-5ed1be54dfb8",
"productndc": "0093-1078",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "065208",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Dec 6, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Dec 6, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFPROZIL",
"proprietary_name": "Cefprozil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065208",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefprozil",
"start_marketing_date": "20051223",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01DC.
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