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United States · US · US:16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141
Sulfasalazine
Orange BookUNIISPLATC A07EC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA07EC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111657126101100 TABLET in 1 CONTAINER (16571-261-01)
- ndc111657126130300 TABLET in 1 CONTAINER (16571-261-30)
Annotations
UNII (FDA Substance ID)
3XC8GUZ6CB
SULFASALAZINE
RxCUI 9524
Orange Book
A219046
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3XC8GUZ6CB",
"rxcui": "9524",
"inchikey": "NCEXYHBECQHGNR-QZQOTICOSA-N",
"display_name": "SULFASALAZINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"88441a9f-b4f9-455d-a355-46fb30699a7b": {
"match": "brand_token",
"title": "SULFASALAZINE TABLET [REMEDYREPACK INC.]",
"spl_version": "15",
"published_date": "2026-01-30"
}
},
"productid": "16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141",
"productndc": "16571-261",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219046",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Nov 4, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFASALAZINE",
"proprietary_name": "Sulfasalazine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219046",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfasalazine",
"start_marketing_date": "20251104",
"active_numerator_strength": "500"
}Related drugs
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