24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule
- RxCUI
- 899511
- RxNorm name
- 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule
- Display name
- 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule
- Full name
- 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:22
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | dd659d39-41f5-4612-8f17-bad602b4784d | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 899511 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | Granules Pharmaceuticals Inc. | abe6862b-3cf3-4aad-98ea-05a5fb54ebec | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 899511 |
| Dexmethylphenidate hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 93e56455-0f15-4ed9-a63a-7fbd0697d520 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 899511 |
| Dexmethylphenidate Hydrochloride Extended-Release | DEXMETHYLPHENIDATE HYDROCHLORIDE | Lannett Company, Inc. | edad7c67-a872-41ad-a8bd-169278693cc2 | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 899511 |
| Focalin XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | Sandoz Inc | 9cf76f62-48aa-4065-94fd-6fc910391ab5 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | 899511 |
| Focalin XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | Novartis Pharmaceuticals Corporation | 1a1da905-42a0-4748-9c39-67eca45deccc | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | 899511 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | b64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 899511 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | d3318fec-a1bc-4e3c-86a9-3f00ec296869 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 899511 |
| Dexmethylphenidate Hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Par Health USA, LLC | e304388e-86a6-4335-abae-0ce79c7c99c6 | 2024-01-31 | Boxed warning, Warnings, Adverse reactions | 899511 |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 77659abe-74be-4092-90fe-cc475726d4ec | 2021-12-17 | Boxed warning, Warnings, Adverse reactions | 899511 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| d3318fec-a1bc-4e3c-86a9-3f00ec296869 | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 104 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | 20240808 |
| b64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 102 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | 20240812 |
| 1a1da905-42a0-4748-9c39-67eca45deccc | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 36 | These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | 20250923 |
| dd659d39-41f5-4612-8f17-bad602b4784d | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 23 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | 20250430 |
| 93e56455-0f15-4ed9-a63a-7fbd0697d520 | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 15 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | 20251009 |
| e304388e-86a6-4335-abae-0ce79c7c99c6 | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 13 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | 20240131 |
| edad7c67-a872-41ad-a8bd-169278693cc2 | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 10 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2001 | 20250925 |
| abe6862b-3cf3-4aad-98ea-05a5fb54ebec | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 9 | Dexmethylphenidate hydrochloride extended-release capsules These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | 20251015 |
| 9cf76f62-48aa-4065-94fd-6fc910391ab5 | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 5 | These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | 20250923 |
| 00f1d83e-93cc-4bbe-9c3b-c488062271ab | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 2 | These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005 | 20101111 |
| 77659abe-74be-4092-90fe-cc475726d4ec | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule [SY] | 3 | 1 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | 20211217 |