mesalamine

Generic: mesalamine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mesalamine .375 g/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1375
Product ID 0378-1375_74ab5fdd-ccdd-403d-af79-fd34a1cc939f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207271
Listing Expiration 2026-12-31
Marketing Start 2019-11-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781375
Hyphenated Format 0378-1375

Supplemental Identifiers

RxCUI
825130
UPC
0303781375788
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 ANDA207271 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 g/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)
source: ndc

Packages (1)

0378-1375-78 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)

Ingredients (1)

mesalamine (.375 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": "74ab5fdd-ccdd-403d-af79-fd34a1cc939f", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0303781375788"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["c8b93ea3-0367-4605-b87f-06c3812ff3b7"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)", "package_ndc": "0378-1375-78", "marketing_start_date": "20191126"}], "brand_name": "Mesalamine", "product_id": "0378-1375_74ab5fdd-ccdd-403d-af79-fd34a1cc939f", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0378-1375", "generic_name": "mesalamine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": ".375 g/1"}], "application_number": "ANDA207271", "marketing_category": "ANDA", "marketing_start_date": "20191126", "listing_expiration_date": "20261231"}