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United States · US · US:67877-243_2e36bf51-2cc6-441a-ad40-6d752e3e4e9b
Cefprozil
Orange BookUNIISPLATC J01DC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeJ01DC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11678772435050 TABLET, FILM COATED in 1 BOTTLE (67877-243-50)
Annotations
UNII (FDA Substance ID)
4W0459ZA4V
CEFPROZIL
RxCUI 19552
Orange Book
A090857
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": "67877-243_2e36bf51-2cc6-441a-ad40-6d752e3e4e9b",
"productndc": "67877-243",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090857",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Apr 9, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Apr 9, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFPROZIL",
"proprietary_name": "Cefprozil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090857",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefprozil",
"start_marketing_date": "20250120",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01DC.
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