Package 0527-8109-37
Brand: dexmethylphenidate hydrochloride extended-release
Generic: dexmethylphenidate hydrochloridePackage Facts
Identity
Package NDC
0527-8109-37
Digits Only
0527810937
Product NDC
0527-8109
Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8109-37)
Marketing
Marketing Status
Brand
dexmethylphenidate hydrochloride extended-release
Generic
dexmethylphenidate hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "05dde601-77db-4253-be20-c4737687633e", "openfda": {"upc": ["0305278113378"], "unii": ["1678OK0E08"], "rxcui": ["899439", "899461", "899485", "899495", "899511", "1006608", "1101926", "1101932"], "spl_set_id": ["edad7c67-a872-41ad-a8bd-169278693cc2"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8109-37)", "package_ndc": "0527-8109-37", "marketing_start_date": "20181009"}], "brand_name": "Dexmethylphenidate Hydrochloride Extended-Release", "product_id": "0527-8109_05dde601-77db-4253-be20-c4737687633e", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0527-8109", "dea_schedule": "CII", "generic_name": "dexmethylphenidate hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA210279", "marketing_category": "ANDA", "marketing_start_date": "20181009", "listing_expiration_date": "20261231"}