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United States · US · US:50268-102_472f9b42-99d2-a541-e063-6294a90a8926

Balsalazide Disodium

Orange BookUNIISPLATC A07EC04

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

Identification

ManufacturerAvPAK
CountryUS (United States)
ATC codeA07EC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5026810213
    30 BLISTER PACK in 1 BOX (50268-102-13) / 1 CAPSULE in 1 BLISTER PACK (50268-102-11)

Annotations

UNII (FDA Substance ID)
1XL6BJI034
BALSALAZIDE DISODIUM
RxCUI 153718
Orange Book
A077883
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1XL6BJI034",
    "rxcui": "153718",
    "inchikey": "XDCNKOBSQURQOZ-MVIJUDHYSA-L",
    "display_name": "BALSALAZIDE DISODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "509b83b6-cde6-393b-8560-557793b6a529": {
      "match": "brand_token",
      "title": "BALSALAZIDE DISODIUM CAPSULE [AVPAK]",
      "spl_version": "10",
      "published_date": "2025-12-31"
    }
  },
  "productid": "50268-102_472f9b42-99d2-a541-e063-6294a90a8926",
  "productndc": "50268-102",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077883",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "001",
        "approval_date": "Dec 28, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BALSALAZIDE DISODIUM",
  "proprietary_name": "Balsalazide Disodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077883",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Balsalazide Disodium",
  "start_marketing_date": "20141106",
  "active_numerator_strength": "750"
}

Related drugs

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