Package 66758-239-31

Brand: focalin xr

Generic: dexmethylphenidate hydrochloride
NDC Package

Package Facts

Identity

Package NDC 66758-239-31
Digits Only 6675823931
Product NDC 66758-239
Description

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-239-31)

Marketing

Marketing Status
Marketed Since 2025-11-17
Brand focalin xr
Generic dexmethylphenidate hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "525ad849-4502-493d-a0a1-67cde0a207f0", "openfda": {"unii": ["1678OK0E08"], "rxcui": ["899439", "899441", "899461", "899463", "899485", "899487", "899495", "899497", "899511", "899513", "1006608", "1006610", "1101926", "1101928", "1101932", "1101934"], "spl_set_id": ["9cf76f62-48aa-4065-94fd-6fc910391ab5"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-239-01)", "package_ndc": "66758-239-01", "marketing_start_date": "20250201"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-239-31)", "package_ndc": "66758-239-31", "marketing_start_date": "20251117"}], "brand_name": "Focalin XR", "product_id": "66758-239_525ad849-4502-493d-a0a1-67cde0a207f0", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "66758-239", "dea_schedule": "CII", "generic_name": "dexmethylphenidate hydrochloride", "labeler_name": "Sandoz Inc", "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_start_date": "20050531", "listing_expiration_date": "20261231"}