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 40 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0434
Product ID 0078-0434_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 00780434
Hyphenated Format 0078-0434

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
  • 40 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules are available as follows: • 5 mg capsules (NDC 0078-0430-05) light-blue, (imprinted “NVR D5”) supplied in bottles of 100 • 10 mg capsules (NDC 0078-0431-05) light caramel (imprinted “NVR D10”) supplied in bottles of 100 • 15 mg capsules (NDC 0078-0493-05) green (imprinted “NVR D15”) supplied in bottles of 100 • 20 mg capsules (NDC 0078-0432-05) white (imprinted “NVR D20”) supplied in bottles of 100 • 25 mg capsules (NDC 0078-0608-05) light-blue and white (imprinted “NVR D25”) supplied in bottles of 100 • 30 mg capsules (NDC 0078-0433-05) light caramel and white (imprinted “NVR D30”) supplied in bottles of 100 • 35 mg capsules (NDC 0078-0609-05) light-blue and light caramel (imprinted “NVR D35”) supplied in bottles of 100 • 40 mg capsules (NDC 0078-0434-05) green and white (imprinted “NVR D40”) supplied in bottles of 100 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).
  • PRINCIPAL DISPLAY PANEL NDC 0078-0430-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 5 mg 100 capsules Dispense with Medication Guide attached or provided separately. NOVARTIS 5mglabel
  • PRINCIPAL DISPLAY PANEL NDC 0078-0431-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 10 mg 100 capsules Dispense with Medication Guide attached or provided separately. NOVARTIS 10mglabel
  • PRINCIPAL DISPLAY PANEL NDC 0078-0493-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 15 mg 100 capsules Dispense with Medication Guide attached or provided separately. NOVARTIS 15mglabel
  • PRINCIPAL DISPLAY PANEL NDC 0078-0432-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 20 mg 100 capsules Dispense with Medication Guide attached or provided separately. NOVARTIS 20mglabel
  • PRINCIPAL DISPLAY PANEL NDC 0078-0608-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 25 mg 100 capsules Dispense in tight container (USP). Dispense with Medication Guide attached or provided separately. NOVARTIS 25mglabel
  • PRINCIPAL DISPLAY PANEL NDC 0078-0433-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 30 mg 100 capsules Dispense in tight container (USP). Dispense with Medication Guide attached or provided separately. NOVARTIS 30mglabel
  • PRINCIPAL DISPLAY PANEL NDC 0078-0609-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 35 mg 100 capsules Dispense in tight container (USP). Dispense with Medication Guide attached or provided separately. NOVARTIS 35mglabel
  • PRINCIPAL DISPLAY PANEL NDC 0078-0434-05 Rx only Focalin XR ® (dexmethylphenidate HCl) extended-release capsules 40 mg 100 capsules Dispense in tight container (USP). Dispense with Medication Guide attached or provided separately. NOVARTIS 40mglabel
source: label

Packages (0)

No package records.

Ingredients (1)

dexmethylphenidate hydrochloride (40 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": [], "brand_name": "Focalin XR", "product_id": "0078-0434_fd5dd3b3-6bdf-437e-a763-1a07f9631121", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0078-0434", "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": "40 mg/1"}], "application_number": "NDA021802", "marketing_category": "NDA", "marketing_end_date": "20261231", "marketing_start_date": "20050531"}