Package 68382-435-28

Brand: mesalamine

Generic: mesalamine
NDC Package

Package Facts

Identity

Package NDC 68382-435-28
Digits Only 6838243528
Product NDC 68382-435
Description

180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)

Marketing

Marketing Status
Marketed Since 2018-08-02
Brand mesalamine
Generic mesalamine
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "c2b40002-6c58-4c89-b178-c915a59cb2dd", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["833234"], "spl_set_id": ["ad8c7930-92e2-4372-a874-da22b9ae333e"], "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": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)", "package_ndc": "68382-435-28", "marketing_start_date": "20180802"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-435-77)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)", "package_ndc": "68382-435-77", "marketing_start_date": "20180802"}], "brand_name": "mesalamine", "product_id": "68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "68382-435", "generic_name": "mesalamine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "800 mg/1"}], "application_number": "ANDA203286", "marketing_category": "ANDA", "marketing_start_date": "20180802", "listing_expiration_date": "20261231"}