Sucralfate

Orange BookUNIISPLATC A02BX02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeA02BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6516206205
420 mL in 1 BOTTLE (65162-062-05)
ndc11
6516206248
10 CUP, UNIT-DOSE in 1 TRAY (65162-062-48) / 10 mL in 1 CUP, UNIT-DOSE (65162-062-47)

Annotations

UNII (FDA Substance ID)

XX73205DH5

SUCRALFATE

RxCUI 10156

Orange Book

A209356

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": "65162-062_71ed86a3-ff8a-4545-9bae-26632466fd80",
  "productndc": "65162-062",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "209356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM/10ML",
        "product_no": "001",
        "approval_date": "Dec 2, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUCRALFATE",
  "proprietary_name": "Sucralfate",
  "active_ingred_unit": "g/10mL",
  "application_number": "ANDA209356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sucralfate Oral",
  "start_marketing_date": "20191202",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A02BX02.

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