mesalamine

Generic: mesalamine

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

Drug Facts

Product Profile

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

mesalamine .375 g/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-452
Product ID 68382-452_1d3ac6ac-1404-492a-890f-5ed6e250b380
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208954
Listing Expiration 2026-12-31
Marketing Start 2021-08-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382452
Hyphenated Format 68382-452

Supplemental Identifiers

RxCUI
825130
UPC
0368382452191
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 ANDA208954 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 g/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-452-19)
source: ndc

Packages (1)

68382-452-19 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-452-19)

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": "1d3ac6ac-1404-492a-890f-5ed6e250b380", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0368382452191"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["cd8493f7-91fd-4c2d-b3d7-c1301825586b"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-452-19)", "package_ndc": "68382-452-19", "marketing_start_date": "20210813"}], "brand_name": "Mesalamine", "product_id": "68382-452_1d3ac6ac-1404-492a-890f-5ed6e250b380", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "68382-452", "generic_name": "Mesalamine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": ".375 g/1"}], "application_number": "ANDA208954", "marketing_category": "ANDA", "marketing_start_date": "20210813", "listing_expiration_date": "20261231"}