Package 0078-0381-05

Brand: focalin

Generic: dexmethylphenidate hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0078-0381-05
Digits Only 0078038105
Product NDC 0078-0381
Description

100 TABLET in 1 BOTTLE (0078-0381-05)

Marketing

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "ffb90063-7d7a-4f9e-ace8-19aebacf2e20", "openfda": {"unii": ["1678OK0E08"], "rxcui": ["899518", "899519", "899548", "899549", "899557", "899559"], "spl_set_id": ["7c552f11-e24a-4d9b-bb8d-be10c928eca8"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0078-0381-05)", "package_ndc": "0078-0381-05", "marketing_end_date": "20260731", "marketing_start_date": "20011130"}], "brand_name": "Focalin", "product_id": "0078-0381_ffb90063-7d7a-4f9e-ace8-19aebacf2e20", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0078-0381", "dea_schedule": "CII", "generic_name": "dexmethylphenidate hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Focalin", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA021278", "marketing_category": "NDA", "marketing_end_date": "20260731", "marketing_start_date": "20011130"}