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United States · US · US:42806-757_69f2d77c-8279-4524-93c2-f199e7973400
SULFADIAZINE
Orange BookUNIISPLATC J01EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEPIC PHARMA, LLC
CountryUS (United States)
ATC codeJ01EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11428067576060 TABLET in 1 BOTTLE (42806-757-60)
Annotations
UNII (FDA Substance ID)
0N7609K889
SULFADIAZINE
RxCUI 10171
Orange Book
A040091
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0N7609K889",
"rxcui": "10171",
"inchikey": "SEEPANYCNGTZFQ-UHFFFAOYSA-N",
"display_name": "SULFADIAZINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6e0e9e1b-2ada-35d0-e053-2991aa0a65fb": {
"match": "brand_token",
"title": "SULFADIAZINE SODIUM POWDER [NANHAI BEISHA PHARMACEUTICAL CO. LTD]",
"spl_version": "2",
"published_date": "2025-08-22"
}
},
"productid": "42806-757_69f2d77c-8279-4524-93c2-f199e7973400",
"productndc": "42806-757",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040091",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "500MG",
"product_no": "001",
"approval_date": "Jul 29, 1994"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFADIAZINE",
"proprietary_name": "SULFADIAZINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040091",
"marketing_category": "ANDA",
"nonproprietary_name": "sulfadiazine",
"start_marketing_date": "20211215",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01EC02.
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