sucralfate

Generic: sucralfate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sucralfate
Generic Name sucralfate
Labeler mylan pharmaceuticals inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

sucralfate 1 g/10mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9205
Product ID 0378-9205_107f926c-dcf7-4a04-a44a-e22ff1534f97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212913
Listing Expiration 2026-12-31
Marketing Start 2022-09-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03789205
Hyphenated Format 0378-9205

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 ANDA212913 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 420 mL in 1 BOTTLE, PLASTIC (0378-9205-35)
source: ndc

Packages (1)

0378-9205-35 420 mL in 1 BOTTLE, PLASTIC (0378-9205-35)

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": "107f926c-dcf7-4a04-a44a-e22ff1534f97", "openfda": {"nui": ["N0000175801", "M0015420"], "unii": ["XX73205DH5"], "rxcui": ["313123"], "spl_set_id": ["1e781cc0-24ec-4028-8262-dcef9873ea1f"], "pharm_class_cs": ["Organometallic Compounds [CS]"], "pharm_class_epc": ["Aluminum Complex [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "420 mL in 1 BOTTLE, PLASTIC (0378-9205-35)", "package_ndc": "0378-9205-35", "marketing_start_date": "20220922"}], "brand_name": "sucralfate", "product_id": "0378-9205_107f926c-dcf7-4a04-a44a-e22ff1534f97", "dosage_form": "SUSPENSION", "pharm_class": ["Aluminum Complex [EPC]", "Organometallic Compounds [CS]"], "product_ndc": "0378-9205", "generic_name": "sucralfate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sucralfate", "active_ingredients": [{"name": "SUCRALFATE", "strength": "1 g/10mL"}], "application_number": "ANDA212913", "marketing_category": "ANDA", "marketing_start_date": "20220922", "listing_expiration_date": "20261231"}