mesalamine

Generic: mesalamine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler avpak
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mesalamine .375 g/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-577
Product ID 50268-577_2b4a9376-8515-3d10-e063-6394a90a0aad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214242
Listing Expiration 2026-12-31
Marketing Start 2023-01-16

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268577
Hyphenated Format 50268-577

Supplemental Identifiers

RxCUI
825130
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

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 mesalamine (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number ANDA214242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 g/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-577-15) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-577-11)
source: ndc

Packages (1)

50268-577-15 50 BLISTER PACK in 1 BOX (50268-577-15) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-577-11)

Ingredients (1)

mesalamine (.375 g/1)

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b4a9376-8515-3d10-e063-6394a90a0aad", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["f2657911-6f06-71fb-e053-2a95a90ae6f7"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-577-15)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-577-11)", "package_ndc": "50268-577-15", "marketing_start_date": "20230116"}], "brand_name": "Mesalamine", "product_id": "50268-577_2b4a9376-8515-3d10-e063-6394a90a0aad", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "50268-577", "generic_name": "Mesalamine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": ".375 g/1"}], "application_number": "ANDA214242", "marketing_category": "ANDA", "marketing_start_date": "20230116", "listing_expiration_date": "20261231"}