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United States · US · US:62135-960_ef9f56ad-c921-6fe7-e053-2a95a90a85af
Sulfasalazine
Orange BookUNIISPLATC A07EC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC.
CountryUS (United States)
ATC codeA07EC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116213596001100 TABLET in 1 BOTTLE (62135-960-01)
- ndc116213596005500 TABLET in 1 BOTTLE (62135-960-05)
- ndc1162135960101000 TABLET in 1 BOTTLE (62135-960-10)
- ndc116213596031300 TABLET in 1 BOTTLE (62135-960-31)
Annotations
UNII (FDA Substance ID)
3XC8GUZ6CB
SULFASALAZINE
RxCUI 9524
Orange Book
A080197
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": "62135-960_ef9f56ad-c921-6fe7-e053-2a95a90a85af",
"productndc": "62135-960",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "080197",
"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": "ANDA080197",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfasalazine",
"start_marketing_date": "19731112",
"active_numerator_strength": "500"
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