Package 0078-0608-05

Brand: focalin xr

Generic: dexmethylphenidate hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0078-0608-05
Digits Only 0078060805
Product NDC 0078-0608
Product ID 0078-0608_fd5dd3b3-6bdf-437e-a763-1a07f9631121
Description

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0608-05)

Marketing

Marketing Status
Discontinued 2026-07-31
Brand focalin xr
Generic dexmethylphenidate hydrochloride
Sample Package No

Linked Drug Pages (1)

Focalin XR ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fd5dd3b3-6bdf-437e-a763-1a07f9631121", "openfda": {"unii": ["1678OK0E08"], "rxcui": ["899439", "899441", "899461", "899463", "899485", "899487", "899495", "899497", "899511", "899513", "1006608", "1006610", "1101926", "1101928", "1101932", "1101934"], "spl_set_id": ["1a1da905-42a0-4748-9c39-67eca45deccc"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0608-05)", "package_ndc": "0078-0608-05", "marketing_end_date": "20260731", "marketing_start_date": "20050531"}], "brand_name": "Focalin XR", "product_id": "0078-0608_fd5dd3b3-6bdf-437e-a763-1a07f9631121", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0078-0608", "dea_schedule": "CII", "generic_name": "dexmethylphenidate hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Focalin", "brand_name_suffix": "XR", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "NDA021802", "marketing_category": "NDA", "marketing_end_date": "20261231", "marketing_start_date": "20050531"}