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United States · US · US:0093-3234_6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471
Sulfasalazine
Orange BookUNIISPLATC A07EC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeA07EC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110093323401100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01)
- ndc110093323405500 TABLET in 1 BOTTLE, PLASTIC (0093-3234-05)
- ndc1100933234101000 TABLET in 1 BOTTLE, PLASTIC (0093-3234-10)
Annotations
UNII (FDA Substance ID)
3XC8GUZ6CB
SULFASALAZINE
RxCUI 9524
Orange Book
A085828
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": "0093-3234_6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471",
"productndc": "0093-3234",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "085828",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFASALAZINE",
"proprietary_name": "Sulfasalazine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA085828",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfasalazine",
"start_marketing_date": "20221215",
"active_numerator_strength": "500"
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