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United States · US · US:70518-1829_4976ef9d-bb2f-1498-e063-6294a90a81d2

Sulfasalazine

Orange BookUNIISPLATC A07EC01

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA07EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051818293
    30 TABLET in 1 BLISTER PACK (70518-1829-3)

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": {
    "88441a9f-b4f9-455d-a355-46fb30699a7b": {
      "match": "brand_token",
      "title": "SULFASALAZINE TABLET [REMEDYREPACK INC.]",
      "spl_version": "15",
      "published_date": "2026-01-30"
    }
  },
  "productid": "70518-1829_4976ef9d-bb2f-1498-e063-6294a90a81d2",
  "productndc": "70518-1829",
  "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": "Sulfasalazine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA007073",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Sulfasalazine",
  "start_marketing_date": "20190128",
  "active_numerator_strength": "500"
}

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