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United States · US · US:0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c

Balsalazide Disodium

Orange BookUNIISPLATC A07EC04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA07EC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0054007928
    280 CAPSULE in 1 BOTTLE (0054-0079-28)

Annotations

UNII (FDA Substance ID)
1XL6BJI034
BALSALAZIDE DISODIUM
RxCUI 153718
Orange Book
A077806
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": "0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c",
  "productndc": "0054-0079",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077806",
    "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": "ANDA077806",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Balsalazide Disodium",
  "start_marketing_date": "20071228",
  "active_numerator_strength": "750"
}

Related drugs

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