Sucralfate

Orange BookUNIISPLATC A02BX02

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma

CountryUS (United States)

ATC codeA02BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0121097400
10 TRAY in 1 TRAY (0121-0974-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)
ndc11
0121097440
4 TRAY in 1 CASE (0121-0974-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)
ndc11
0121097450
5 PACKAGE in 1 TRAY (0121-0974-50) / 10 CUP, UNIT-DOSE in 1 PACKAGE / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)
ndc11
0121097494
3 TRAY in 1 CASE (0121-0974-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)

Annotations

UNII (FDA Substance ID)

XX73205DH5

SUCRALFATE

RxCUI 10156

Orange Book

A211884

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": "0121-0974_2271d920-944f-42ac-9de4-2c09447a55b3",
  "productndc": "0121-0974",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "211884",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM/10ML",
        "product_no": "001",
        "approval_date": "Mar 15, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUCRALFATE",
  "proprietary_name": "Sucralfate",
  "active_ingred_unit": "g/10mL",
  "application_number": "ANDA211884",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sucralfate",
  "start_marketing_date": "20220315",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A02BX02.

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