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United States · US · US:0013-0102_f4631374-60aa-4e49-ac58-632f9cbdea08

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

  • ndc11
    0013010250
    1 BOTTLE in 1 CARTON (0013-0102-50) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    0013010260
    1 BOTTLE in 1 CARTON (0013-0102-60) / 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": {
    "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": "0013-0102_f4631374-60aa-4e49-ac58-632f9cbdea08",
  "productndc": "0013-0102",
  "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": "Azulfidine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA007073",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sulfasalazine",
  "start_marketing_date": "19500620",
  "active_numerator_strength": "500"
}

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