mesalamine

Generic: mesalamine

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler northstar rxllc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 1.2 g/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-304
Product ID 72603-304_276b312e-ae4d-9ca2-e063-6294a90a55c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216334
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603304
Hyphenated Format 72603-304

Supplemental Identifiers

RxCUI
686429
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 ANDA216334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-304-01)
source: ndc

Packages (1)

72603-304-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-304-01)

Ingredients (1)

mesalamine (1.2 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": "276b312e-ae4d-9ca2-e063-6294a90a55c7", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["8233f158-9da5-4fd2-b2c3-9db89448371f"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-304-01)", "package_ndc": "72603-304-01", "marketing_start_date": "20241201"}], "brand_name": "Mesalamine", "product_id": "72603-304_276b312e-ae4d-9ca2-e063-6294a90a55c7", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "72603-304", "generic_name": "Mesalamine", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA216334", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}