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United States · US · US:68462-827_1e595c2a-edd0-43f7-a2db-69553b9557d9

Sucralfate oral suspension

Orange BookUNIISPLATC A02BX02

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeA02BX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6846282761
    420 mL in 1 BOTTLE (68462-827-61)

Annotations

UNII (FDA Substance ID)
XX73205DH5
SUCRALFATE
RxCUI 10156
Orange Book
A212141
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "XX73205DH5",
    "rxcui": "10156",
    "inchikey": "IPLJAZDIICJQEL-JTJNLBSYSA-A",
    "display_name": "SUCRALFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cd25eb96-29ea-48b2-bdee-c2ea98f216b8": {
      "match": "brand_token",
      "title": "SUCRALFATE TABLET [ASCLEMED USA INC.]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "68462-827_1e595c2a-edd0-43f7-a2db-69553b9557d9",
  "productndc": "68462-827",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "212141",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM/10ML",
        "product_no": "001",
        "approval_date": "Jan 5, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUCRALFATE",
  "proprietary_name": "Sucralfate oral suspension",
  "active_ingred_unit": "g/10mL",
  "application_number": "ANDA212141",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sucralfate",
  "start_marketing_date": "20260105",
  "active_numerator_strength": "1"
}

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