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United States · US · US:11534-200_97b74888-4b28-4f9a-b5b9-64d23bc7e808
Sulfasalazine
Orange BookUNIISPLATC A07EC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSunrise Pharmaceutical, Inc.
CountryUS (United States)
ATC codeA07EC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111153420001100 TABLET in 1 BOTTLE (11534-200-01)
- ndc111153420004500 TABLET in 1 BOTTLE (11534-200-04)
- ndc111153420007300 TABLET in 1 BOTTLE (11534-200-07)
Annotations
UNII (FDA Substance ID)
3XC8GUZ6CB
SULFASALAZINE
RxCUI 9524
Orange Book
A040349
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": "11534-200_97b74888-4b28-4f9a-b5b9-64d23bc7e808",
"productndc": "11534-200",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040349",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jan 11, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFASALAZINE",
"proprietary_name": "Sulfasalazine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040349",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfasalazine",
"start_marketing_date": "20250715",
"active_numerator_strength": "500"
}Related drugs
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