Package 75834-328-01
Brand: dexmethylphenidate hydrochloride
Generic: dexmethylphenidate hydrochloridePackage Facts
Identity
Package NDC
75834-328-01
Digits Only
7583432801
Product NDC
75834-328
Description
100 TABLET in 1 BOTTLE (75834-328-01)
Marketing
Marketing Status
Brand
dexmethylphenidate hydrochloride
Generic
dexmethylphenidate hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6103914c-da93-4648-9180-e5c439a07bc2", "openfda": {"upc": ["0375834328010", "0375834327013"], "unii": ["1678OK0E08"], "rxcui": ["899518", "899548"], "spl_set_id": ["638f614c-bf91-4bf6-876f-bf25fa273bc4"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-328-01)", "package_ndc": "75834-328-01", "marketing_start_date": "20240503"}], "brand_name": "Dexmethylphenidate hydrochloride", "product_id": "75834-328_6103914c-da93-4648-9180-e5c439a07bc2", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "75834-328", "dea_schedule": "CII", "generic_name": "Dexmethylphenidate hydrochloride", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate hydrochloride", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209211", "marketing_category": "ANDA", "marketing_start_date": "20240503", "listing_expiration_date": "20271231"}