mesalamine

Generic: mesalamine

Labeler: lannett company inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler lannett company inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 1.2 g/1

Manufacturer
Lannett Company Inc.

Identifiers & Regulatory

Product NDC 0527-3012
Product ID 0527-3012_81f0e9e6-e117-46fa-b0e6-c423f63bd3d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217337
Listing Expiration 2026-12-31
Marketing Start 2023-06-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05273012
Hyphenated Format 0527-3012

Supplemental Identifiers

RxCUI
686429
UPC
0305273012485
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 ANDA217337 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-3012-48)
source: ndc

Packages (1)

0527-3012-48 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-3012-48)

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": "81f0e9e6-e117-46fa-b0e6-c423f63bd3d3", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0305273012485"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["29dbe417-15a9-4c4d-846b-81cabda7ac70"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Lannett Company Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-3012-48)", "package_ndc": "0527-3012-48", "marketing_start_date": "20230603"}], "brand_name": "MESALAMINE", "product_id": "0527-3012_81f0e9e6-e117-46fa-b0e6-c423f63bd3d3", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0527-3012", "generic_name": "mesalamine", "labeler_name": "Lannett Company Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MESALAMINE", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA217337", "marketing_category": "ANDA", "marketing_start_date": "20230603", "listing_expiration_date": "20261231"}