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United States · US · US:0013-0101_8d2e14e3-000c-41bb-82d4-c9a67330e0d9
Azulfidine
Orange BookUNIISPLATC A07EC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeA07EC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100130101101 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLE
- ndc1100130101301 BOTTLE in 1 CARTON (0013-0101-30) / 300 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
3XC8GUZ6CB
SULFASALAZINE
RxCUI 9524
Orange Book
N007073
ABAB
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": {
"b9ef541a-93c8-4428-ba45-398aa0b327d1": {
"match": "brand_token",
"title": "AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "34",
"published_date": "2026-06-01"
}
},
"productid": "0013-0101_8d2e14e3-000c-41bb-82d4-c9a67330e0d9",
"productndc": "0013-0101",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "007073",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Apr 6, 1983"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFASALAZINE",
"proprietary_name": "Azulfidine",
"active_ingred_unit": "mg/1",
"application_number": "NDA007073",
"marketing_category": "NDA",
"nonproprietary_name": "Sulfasalazine",
"start_marketing_date": "19500620",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code A07EC01.
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