mesalamine

Generic: mesalamine

Labeler: sun pharmaceutical industries inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler sun pharmaceutical industries inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 500 mg/1

Manufacturer
Sun Pharmaceutical Industries Inc.

Identifiers & Regulatory

Product NDC 63304-089
Product ID 63304-089_d41a599a-71be-4294-9b53-d1cbefe905d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214585
Listing Expiration 2026-12-31
Marketing Start 2022-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304089
Hyphenated Format 63304-089

Supplemental Identifiers

RxCUI
476362
UPC
0363304089134
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

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 mesalamine (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number ANDA214585 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13)
source: ndc

Packages (1)

63304-089-13 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13)

Ingredients (1)

mesalamine (500 mg/1)

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d41a599a-71be-4294-9b53-d1cbefe905d5", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0363304089134"], "unii": ["4Q81I59GXC"], "rxcui": ["476362"], "spl_set_id": ["c2f84490-70b8-4998-907d-a77e9f791de1"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13)", "package_ndc": "63304-089-13", "marketing_start_date": "20220513"}], "brand_name": "Mesalamine", "product_id": "63304-089_d41a599a-71be-4294-9b53-d1cbefe905d5", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "63304-089", "generic_name": "Mesalamine", "labeler_name": "Sun Pharmaceutical Industries Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "500 mg/1"}], "application_number": "ANDA214585", "marketing_category": "ANDA", "marketing_start_date": "20220513", "listing_expiration_date": "20261231"}