Package 0378-1375-78

Brand: mesalamine

Generic: mesalamine
NDC Package

Package Facts

Identity

Package NDC 0378-1375-78
Digits Only 0378137578
Product NDC 0378-1375
Product ID 0378-1375_74ab5fdd-ccdd-403d-af79-fd34a1cc939f
Description

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

Marketing

Marketing Status
Marketed Since 2019-11-26
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": "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"}