Active substance
Dexmethylphenidate
- US FDA 23
- US price lines 22
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FOCALIN | 2.5MG; 5MG; 10MG | tablet · oral | SANDOZ | Prescription | 13 Nov 2001 |
| FOCALIN XR | 5MG; 10MG; 20MG; 15MG; 30MG; 40MG; 35MG; 25MG | capsule, extended release · oral | SANDOZ | Prescription | 26 May 2005 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 15MG; 30MG; 20MG; 40MG | capsule, extended release · oral | PLATINUM | Prescription | 18 Nov 2013 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 20MG; 15MG | capsule, extended release · oral | TEVA PHARMS USA | Prescription | 19 Nov 2013 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG; 40MG; 30MG; 35MG | capsule, extended release · oral | TEVA PHARMS USA | Prescription | 19 Nov 2013 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 15MG; 20MG; 30MG | capsule, extended release · oral | IMPAX LABS INC | Prescription | 21 Nov 2013 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG; 5MG; 10MG | tablet · oral | SUN PHARM INDUSTRIES | Prescription | 24 Sep 2015 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG; 5MG; 10MG | tablet · oral | NOVEL LABS INC | Prescription | 4 Dec 2015 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG; 5MG; 10MG | tablet · oral | ABHAI LLC | Prescription | 4 Dec 2015 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG; 5MG; 10MG | tablet · oral | TRIS PHARMA INC | Prescription | 26 Aug 2016 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 15MG; 20MG; 25MG; 30MG; 35MG; 40MG | capsule, extended release · oral | PH HEALTH | Prescription | 30 Nov 2016 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG; 35MG | capsule, extended release · oral | IMPAX LABS INC | Prescription | 5 Jul 2017 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | CEDIPROF INC | Prescription | 19 Sep 2018 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 15MG; 20MG; 25MG; 30MG; 35MG; 40MG | capsule, extended release · oral | ADARE PHARMS INC | Prescription | 9 Oct 2018 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG; 5MG; 10MG | tablet · oral | ALKEM LABS LTD | Prescription | 19 Jul 2019 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 15MG; 20MG; 25MG; 30MG; 35MG; 40MG | capsule, extended release · oral | GRANULES | Prescription | 9 Sep 2020 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 15MG; 20MG; 25MG; 30MG; 35MG; 40MG | capsule, extended release · oral | ASCENT PHARMS INC | Prescription | 8 Dec 2021 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 2.5MG | tablet · oral | TEVA PHARMS | Discontinued | 29 Jan 2007 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG; 5MG; 10MG; 15MG; 20MG; 25MG; 35MG; 40MG | capsule, extended release · oral | AUROLIFE PHARMA LLC | Discontinued | 28 Aug 2013 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG; 5MG; 10MG | tablet · oral | LANNETT CO INC | Discontinued | 25 Sep 2017 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG; 5MG; 10MG | tablet · oral | RHODES PHARMS | Discontinued | 20 Nov 2017 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | BIONPHARMA | Discontinued | 24 Mar 2020 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG; 10MG; 15MG; 20MG; 25MG; 30MG; 35MG; 40MG | capsule, extended release · oral | SUN PHARM INDS INC | Discontinued | 5 Nov 2021 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DEXMETHYLPHENIDATE 10 MG TAB | $0.34138 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE 2.5 MG TAB | $0.19002 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE 5 MG TAB | $0.26984 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 10 MG CP | $1.45204 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 15 MG CP | $0.79814 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 20 MG CP | $1.6924 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 25 MG CP | $1.75805 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 30 MG CP | $1.55941 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 35 MG CP | $2.07153 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 40 MG CP | $1.65667 | per EA | 23 Sep 2026 |
| US NADAC | DEXMETHYLPHENIDATE ER 5 MG CAP | $1.01375 | per EA | 23 Sep 2026 |
| US NADAC | FOCALIN 10 MG TABLET | $1.32932 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 23 Sep 2025 AZSTARYS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Sep 2025 FOCALIN XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Oct 2023 FOCALIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.