Sulfasalazine

Orange BookUNIISPLATC A07EC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA07EC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5976201045
1 BOTTLE in 1 CARTON (59762-0104-5) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE
ndc11
5976201046
1 BOTTLE in 1 CARTON (59762-0104-6) / 300 TABLET, DELAYED RELEASE 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": {
    "88441a9f-b4f9-455d-a355-46fb30699a7b": {
      "match": "brand_token",
      "title": "SULFASALAZINE TABLET [REMEDYREPACK INC.]",
      "spl_version": "15",
      "published_date": "2026-01-30"
    }
  },
  "productid": "59762-0104_d2a8dbd7-49db-4839-a5ee-0cbb39ae17ea",
  "productndc": "59762-0104",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "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": "20050505",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code A07EC01.

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