mesalamine

Generic: mesalamine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler bryant ranch prepack
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 1.2 g/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2231
Product ID 72162-2231_baa76dde-3c5b-4ff4-ba0c-f19660a796c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203817
Listing Expiration 2026-12-31
Marketing Start 2018-03-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622231
Hyphenated Format 72162-2231

Supplemental Identifiers

RxCUI
686429
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 ANDA203817 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2231-2)
source: ndc

Packages (1)

72162-2231-2 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2231-2)

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": "baa76dde-3c5b-4ff4-ba0c-f19660a796c1", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["baa76dde-3c5b-4ff4-ba0c-f19660a796c1"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2231-2)", "package_ndc": "72162-2231-2", "marketing_start_date": "20240814"}], "brand_name": "Mesalamine", "product_id": "72162-2231_baa76dde-3c5b-4ff4-ba0c-f19660a796c1", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "72162-2231", "generic_name": "Mesalamine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA203817", "marketing_category": "ANDA", "marketing_start_date": "20180326", "listing_expiration_date": "20261231"}