focalin xr

Generic: dexmethylphenidate hydrochloride

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name focalin xr
Generic Name dexmethylphenidate hydrochloride
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 30 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0433
Product ID 0078-0433_fd5dd3b3-6bdf-437e-a763-1a07f9631121
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021802
DEA Schedule cii
Marketing Start 2005-05-31
Marketing End 2026-12-31

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 00780433
Hyphenated Format 0078-0433

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
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05)
source: ndc

Packages (1)

0078-0433-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05)

Ingredients (1)

dexmethylphenidate hydrochloride (30 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": "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 (0078-0433-05)", "package_ndc": "0078-0433-05", "marketing_end_date": "20261031", "marketing_start_date": "20050531"}], "brand_name": "Focalin XR", "product_id": "0078-0433_fd5dd3b3-6bdf-437e-a763-1a07f9631121", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0078-0433", "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": "30 mg/1"}], "application_number": "NDA021802", "marketing_category": "NDA", "marketing_end_date": "20261231", "marketing_start_date": "20050531"}