Package 50458-585-01
Brand: concerta
Generic: methylphenidate hydrochloridePackage Facts
Identity
Package NDC
50458-585-01
Digits Only
5045858501
Product NDC
50458-585
Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01)
Marketing
Marketing Status
Brand
concerta
Generic
methylphenidate hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "37e34ae6-39c5-4f74-89eb-eadec80792fd", "openfda": {"upc": ["0350458585018", "0350458587012", "0350458588019", "0350458586015"], "unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091157", "1091170", "1091172", "1091185", "1091187", "1091210", "1091212"], "spl_set_id": ["1a88218c-5b18-4220-8f56-526de1a276cd"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01)", "package_ndc": "50458-585-01", "marketing_start_date": "20000801"}], "brand_name": "CONCERTA", "product_id": "50458-585_37e34ae6-39c5-4f74-89eb-eadec80792fd", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "50458-585", "dea_schedule": "CII", "generic_name": "Methylphenidate hydrochloride", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CONCERTA", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "18 mg/1"}], "application_number": "NDA021121", "marketing_category": "NDA", "marketing_start_date": "20000801", "listing_expiration_date": "20271231"}