mesalamine

Generic: mesalamine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mesalamine 1.2 g/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6832
Product ID 0904-6832_cf19237e-af40-4db5-96e6-c53e6a6d4b59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091640
Listing Expiration 2026-12-31
Marketing Start 2017-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046832
Hyphenated Format 0904-6832

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 ANDA091640 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6832-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6832-04 30 BLISTER PACK in 1 CARTON (0904-6832-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

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": "cf19237e-af40-4db5-96e6-c53e6a6d4b59", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["14ac4435-903b-41f5-a3c4-8c73de3e4cef"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6832-04)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6832-04", "marketing_start_date": "20170619"}], "brand_name": "mesalamine", "product_id": "0904-6832_cf19237e-af40-4db5-96e6-c53e6a6d4b59", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0904-6832", "generic_name": "mesalamine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA091640", "marketing_category": "ANDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}