mesalamine

Generic: mesalamine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 800 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-360
Product ID 65162-360_8a17cdb3-a542-4ebd-acef-3a7304f36b7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215067
Listing Expiration 2026-12-31
Marketing Start 2025-02-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162360
Hyphenated Format 65162-360

Supplemental Identifiers

RxCUI
833234
UPC
0365162360189
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 ANDA215067 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18)
source: ndc

Packages (1)

65162-360-18 180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18)

Ingredients (1)

mesalamine (800 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": "8a17cdb3-a542-4ebd-acef-3a7304f36b7a", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0365162360189"], "unii": ["4Q81I59GXC"], "rxcui": ["833234"], "spl_set_id": ["00f77203-3615-47e8-ae25-6e1cf8a2a00a"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18)", "package_ndc": "65162-360-18", "marketing_start_date": "20250219"}], "brand_name": "Mesalamine", "product_id": "65162-360_8a17cdb3-a542-4ebd-acef-3a7304f36b7a", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "65162-360", "generic_name": "Mesalamine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "800 mg/1"}], "application_number": "ANDA215067", "marketing_category": "ANDA", "marketing_start_date": "20250219", "listing_expiration_date": "20261231"}