sucralfate

Generic: sucralfate oral

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sucralfate
Generic Name sucralfate oral
Labeler amneal pharmaceuticals llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

sucralfate 1 g/10mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-062
Product ID 65162-062_71ed86a3-ff8a-4545-9bae-26632466fd80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209356
Listing Expiration 2026-12-31
Marketing Start 2019-12-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162062
Hyphenated Format 65162-062

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 oral (source: ndc)
Application Number ANDA209356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 420 mL in 1 BOTTLE (65162-062-05)
  • 10 CUP, UNIT-DOSE in 1 TRAY (65162-062-48) / 10 mL in 1 CUP, UNIT-DOSE (65162-062-47)
source: ndc

Packages (2)

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

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": "71ed86a3-ff8a-4545-9bae-26632466fd80", "openfda": {"nui": ["N0000175801", "M0015420"], "unii": ["XX73205DH5"], "rxcui": ["313123"], "spl_set_id": ["4350b771-76a9-4e00-93f0-a18c71288f83"], "pharm_class_cs": ["Organometallic Compounds [CS]"], "pharm_class_epc": ["Aluminum Complex [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "420 mL in 1 BOTTLE (65162-062-05)", "package_ndc": "65162-062-05", "marketing_start_date": "20191202"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (65162-062-48)  / 10 mL in 1 CUP, UNIT-DOSE (65162-062-47)", "package_ndc": "65162-062-48", "marketing_start_date": "20191202"}], "brand_name": "Sucralfate", "product_id": "65162-062_71ed86a3-ff8a-4545-9bae-26632466fd80", "dosage_form": "SUSPENSION", "pharm_class": ["Aluminum Complex [EPC]", "Organometallic Compounds [CS]"], "product_ndc": "65162-062", "generic_name": "Sucralfate Oral", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sucralfate", "active_ingredients": [{"name": "SUCRALFATE", "strength": "1 g/10mL"}], "application_number": "ANDA209356", "marketing_category": "ANDA", "marketing_start_date": "20191202", "listing_expiration_date": "20261231"}