focalin xr

Generic: dexmethylphenidate hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name focalin xr
Generic Name dexmethylphenidate hydrochloride
Labeler sandoz inc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 20 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-238
Product ID 66758-238_525ad849-4502-493d-a0a1-67cde0a207f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021802
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2005-05-31

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66758238
Hyphenated Format 66758-238

Supplemental Identifiers

RxCUI
899439 899441 899461 899463 899485 899487 899495 899497 899511 899513 1006608 1006610 1101926 1101928 1101932 1101934
UNII
1678OK0E08

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name focalin xr (source: ndc)
Generic Name dexmethylphenidate hydrochloride (source: ndc)
Application Number NDA021802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-238-01)
source: ndc

Packages (1)

66758-238-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-238-01)

Ingredients (1)

dexmethylphenidate hydrochloride (20 mg/1)

Linked Drug Pages (1)

Focalin XR ndc-match (0.9)

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 (66758-238-01)", "package_ndc": "66758-238-01", "marketing_start_date": "20241004"}], "brand_name": "Focalin XR", "product_id": "66758-238_525ad849-4502-493d-a0a1-67cde0a207f0", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "66758-238", "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": "20 mg/1"}], "application_number": "NDA021802", "marketing_category": "NDA", "marketing_start_date": "20050531", "listing_expiration_date": "20261231"}