United States · FDA National Drug Code directory
Focalin XR
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 0078-0493_fd5dd3b3-6bdf-437e-a763-1a07f9631121
- Product NDC
- 0078-0493
- Form
- CAPSULE, EXTENDED RELEASE
- Composition / generic term
- dexmethylphenidate hydrochloride
- Labeler
- Novartis Pharmaceuticals Corporation
- Marketing category
- NDA
- Marketing start / end (source format)
- 20050531 / 20261231
Source-listed ingredients
- DEXMETHYLPHENIDATE HYDROCHLORIDE — 15 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
Package details are not available in this snapshot.
Source and coverage
Open FDA National Drug Code directory →
Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
Browse United States records →