Package 68382-711-64

Brand: mesalamine

Generic: mesalamine
NDC Package

Package Facts

Identity

Package NDC 68382-711-64
Digits Only 6838271164
Product NDC 68382-711
Description

34 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64)

Marketing

Marketing Status
Marketed Since 2017-06-19
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": "d9ce9589-6aee-4dc3-a71b-f1c32ab9f552", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0368382711199"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["533bfaf5-0add-4b49-a4f2-ddea2b83f65d"], "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 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-19)", "package_ndc": "68382-711-19", "marketing_start_date": "20170619"}, {"sample": false, "description": "34 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64)", "package_ndc": "68382-711-64", "marketing_start_date": "20170619"}], "brand_name": "mesalamine", "product_id": "68382-711_d9ce9589-6aee-4dc3-a71b-f1c32ab9f552", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "68382-711", "generic_name": "mesalamine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA091640", "marketing_category": "ANDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}