Package 68382-452-19

Brand: mesalamine

Generic: mesalamine
NDC Package

Package Facts

Identity

Package NDC 68382-452-19
Digits Only 6838245219
Product NDC 68382-452
Product ID 68382-452_1d3ac6ac-1404-492a-890f-5ed6e250b380
Description

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

Marketing

Marketing Status
Marketed Since 2021-08-13
Brand mesalamine
Generic mesalamine
Sample Package No

Linked Drug Pages (1)

Mesalamine ndc-match (0.95)

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"}