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United States · US · US:16714-398_1fef82c2-7104-4649-bf85-6d7bef37262e
Cefprozil
Orange BookUNIISPLATC J01DC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC codeJ01DC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111671439801100 TABLET, FILM COATED in 1 BOTTLE (16714-398-01)
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": "16714-398_1fef82c2-7104-4649-bf85-6d7bef37262e",
"productndc": "16714-398",
"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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