focalin

Generic: dexmethylphenidate hydrochloride

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

Drug Facts

Product Profile

Brand Name focalin
Generic Name dexmethylphenidate hydrochloride
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 10 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0382
Product ID 0078-0382_ffb90063-7d7a-4f9e-ace8-19aebacf2e20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021278
DEA Schedule cii
Marketing Start 2001-11-30
Marketing End 2026-07-31

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 00780382
Hyphenated Format 0078-0382

Supplemental Identifiers

RxCUI
899518 899519 899548 899549 899557 899559
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 (source: ndc)
Generic Name dexmethylphenidate hydrochloride (source: ndc)
Application Number NDA021278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Focalin (dexmethylphenidate hydrochloride) tablets (D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face) are available as follows: • 2.5 mg tablets (NDC 0078-0380-05) blue, supplied in bottles of 100 • 5 mg tablets (NDC 0078-0381-05) yellow, supplied in bottles of 100 • 10 mg tablets (NDC 0078-0382-05) white, 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, light-resistant container (USP).
  • PRINCIPAL DISPLAY PANEL NOVARTIS NDC 0078-0380-05 Focalin ® dexmethylphenidate hydrochloride 2.5 mg 100 Tablets Rx only Dispense with Medication Guide attached or provided separately. PRINCIPAL DISPLAY PANEL NOVARTIS NDC 0078-0380-05 Focalin® dexmethylphenidate hydrochloride 2.5 mg 100 tablets Rx only Dispense with Medication Guide attached or provided separately.
  • PRINCIPAL DISPLAY PANEL NOVARTIS NDC 0078-0381-05 Focalin ® dexmethylphenidate hydrochloride 5 mg 100 Tablets Rx only Dispense with Medication Guide attached or provided separately. PRINCIPAL DISPLAY PANEL NOVARTIS NDC 0078-0381-05 Focalin® dexmethylphenidate hydrochloride 5 mg 100 tablets Rx only Dispense with Medication Guide attached or provided separately.
  • PRINCIPAL DISPLAY PANEL NOVARTIS NDC 0078-0382-05 Focalin ® dexmethylphenidate hydrochloride 10 mg 100 Tablets Rx only Dispense with Medication Guide attached or provided separately. PRINCIPAL DISPLAY PANEL NOVARTIS NDC 0078-0382-05 Focalin® dexmethylphenidate hydrochloride 10 mg 100 tablets Rx only Dispense with Medication Guide attached or provided separately.
source: label

Packages (0)

No package records.

Ingredients (1)

dexmethylphenidate hydrochloride (10 mg/1)

Linked Drug Pages (1)

Focalin ndc-match (0.9)

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": [], "brand_name": "Focalin", "product_id": "0078-0382_ffb90063-7d7a-4f9e-ace8-19aebacf2e20", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0078-0382", "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": "10 mg/1"}], "application_number": "NDA021278", "marketing_category": "NDA", "marketing_end_date": "20260731", "marketing_start_date": "20011130"}