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United States · US · US:16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141

Sulfasalazine

Orange BookUNIISPLATC A07EC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA07EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1657126101
    100 TABLET in 1 CONTAINER (16571-261-01)
  • ndc11
    1657126130
    300 TABLET in 1 CONTAINER (16571-261-30)

Annotations

UNII (FDA Substance ID)
3XC8GUZ6CB
SULFASALAZINE
RxCUI 9524
Orange Book
A219046
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": "16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141",
  "productndc": "16571-261",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219046",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULFASALAZINE",
  "proprietary_name": "Sulfasalazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219046",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfasalazine",
  "start_marketing_date": "20251104",
  "active_numerator_strength": "500"
}

Related drugs

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