sucralfate

Generic: sucralfate

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sucralfate
Generic Name sucralfate
Labeler pai holdings, llc dba pai pharma
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

sucralfate 1 g/10mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0974
Product ID 0121-0974_76b5c0b5-ccbd-45d9-abdd-7521af17d1cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211884
Listing Expiration 2026-12-31
Marketing Start 2022-03-15

Pharmacologic Class

Established (EPC)
aluminum complex [epc]
Chemical Structure
organometallic compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210974
Hyphenated Format 0121-0974

Supplemental Identifiers

RxCUI
313123
UNII
XX73205DH5
NUI
N0000175801 M0015420

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sucralfate (source: ndc)
Generic Name sucralfate (source: ndc)
Application Number ANDA211884 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 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)
  • 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)
  • 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)
  • 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)
source: ndc

Packages (4)

0121-0974-00 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) 0121-0974-40 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) 0121-0974-50 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) 0121-0974-94 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)

Ingredients (1)

sucralfate (1 g/10mL)

Linked Drug Pages (1)

Sucralfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "76b5c0b5-ccbd-45d9-abdd-7521af17d1cb", "openfda": {"nui": ["N0000175801", "M0015420"], "unii": ["XX73205DH5"], "rxcui": ["313123"], "spl_set_id": ["113a068a-2ce9-421c-8b89-87ce30e19225"], "pharm_class_cs": ["Organometallic Compounds [CS]"], "pharm_class_epc": ["Aluminum Complex [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "0121-0974-00", "marketing_start_date": "20220831"}, {"sample": false, "description": "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)", "package_ndc": "0121-0974-40", "marketing_start_date": "20220831"}, {"sample": false, "description": "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)", "package_ndc": "0121-0974-50", "marketing_start_date": "20220831"}, {"sample": false, "description": "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)", "package_ndc": "0121-0974-94", "marketing_start_date": "20220831"}], "brand_name": "Sucralfate", "product_id": "0121-0974_76b5c0b5-ccbd-45d9-abdd-7521af17d1cb", "dosage_form": "SUSPENSION", "pharm_class": ["Aluminum Complex [EPC]", "Organometallic Compounds [CS]"], "product_ndc": "0121-0974", "generic_name": "Sucralfate", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sucralfate", "active_ingredients": [{"name": "SUCRALFATE", "strength": "1 g/10mL"}], "application_number": "ANDA211884", "marketing_category": "ANDA", "marketing_start_date": "20220315", "listing_expiration_date": "20261231"}