Back to search
🇺🇸

United States · US · US:11534-201_86d69175-60ab-4573-9c76-b995fc3a7802

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 · 2

  • ndc11
    1153420101
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01)
  • ndc11
    1153420107
    300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07)

Annotations

UNII (FDA Substance ID)
3XC8GUZ6CB
SULFASALAZINE
RxCUI 9524
Orange Book
A075339
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": "11534-201_86d69175-60ab-4573-9c76-b995fc3a7802",
  "productndc": "11534-201",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "075339",
    "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": "ANDA075339",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfasalazine",
  "start_marketing_date": "20251211",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code A07EC01.

Access this data programmatically

Query Sulfasalazine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.