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United States · US · US:70771-1841_1e89905a-c8b9-4083-b5de-2b6429482dd9

balsalazide disodium

Orange BookUNIISPLATC A07EC04

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

Identification

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

Packs · 1

  • ndc11
    7077118411
    280 CAPSULE in 1 BOTTLE (70771-1841-1)

Annotations

UNII (FDA Substance ID)
1XL6BJI034
BALSALAZIDE DISODIUM
RxCUI 153718
Orange Book
A217592
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": "70771-1841_1e89905a-c8b9-4083-b5de-2b6429482dd9",
  "productndc": "70771-1841",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217592",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "001",
        "approval_date": "Jun 8, 2023"
      }
    ],
    "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": "ANDA217592",
  "marketing_category": "ANDA",
  "nonproprietary_name": "balsalazide disodium",
  "start_marketing_date": "20230825",
  "active_numerator_strength": "750"
}

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