mesalamine

Generic: mesalamine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mesalamine 800 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-489
Product ID 42291-489_485f7bde-a4c9-b05b-e063-6394a90a34cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213191
Listing Expiration 2027-12-31
Marketing Start 2024-09-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291489
Hyphenated Format 42291-489

Supplemental Identifiers

RxCUI
833234
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 ANDA213191 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-489-18)
source: ndc

Packages (1)

42291-489-18 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-489-18)

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": "485f7bde-a4c9-b05b-e063-6394a90a34cf", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["833234"], "spl_set_id": ["22f3ee49-ac57-84f5-e063-6394a90aae91"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-489-18)", "package_ndc": "42291-489-18", "marketing_start_date": "20240925"}], "brand_name": "Mesalamine", "product_id": "42291-489_485f7bde-a4c9-b05b-e063-6394a90a34cf", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "42291-489", "generic_name": "Mesalamine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "800 mg/1"}], "application_number": "ANDA213191", "marketing_category": "ANDA", "marketing_start_date": "20240925", "listing_expiration_date": "20271231"}