CiteFacts · FDA Drug Shortages · FDA source
FDA shortage status: Methylphenidate Hydrochloride Tablet, Extended Release
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2023-07-26. Latest FDA row update: 2026-10-01.
FDA lists 34 package records, with companies: Actavis Pharma, Inc., Janssen Pharmaceuticals, Janssen Pharmaceuticals, Inc., Lannett Company, Inc., Sun Pharmaceutical Industries, Inc., Teva Pharmaceuticals USA, Inc., Trigen Laboratories, LLC, Vertical Pharmaceuticals, LLC. Package NDCs: 13811-700-30, 13811-706-10, 13811-707-10, 13811-708-10, 13811-709-10, 13811-710-30, 13811-711-30, 50458-585-01, 50458-586-01, 50458-587-01, 50458-588-01, 57664-606-88, 57664-607-88, 57664-608-88, 57664-609-88, 62037-725-01, 62037-726-01, 62037-727-01, 62037-734-01, 62175-310-37, 62175-311-37, 62175-312-37, 62175-313-37, 68025-084-30, 68025-088-30, 68025-089-30, 68025-095-10, 68025-095-30, 68025-096-10, 68025-096-30, 68025-097-10, 68025-097-30, 68025-098-10, 68025-098-30.
FDA shortage reason: Demand increase for the drug; Discontinuation of the manufacture of the drug; Other
This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.
FDA package and manufacturer records
| Company | Package NDC | Presentation | FDA availability field | FDA update |
|---|---|---|---|---|
| Janssen Pharmaceuticals | 50458-585-01 | Concerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01) | Available | 2026-09-17 |
| Janssen Pharmaceuticals | 50458-588-01 | Concerta, Tablet, Extended Release, 27 mg (NDC 50458-588-01) | Available | 2026-09-17 |
| Janssen Pharmaceuticals | 50458-586-01 | Concerta, Tablet, Extended Release, 36 mg (NDC 50458-586-01) | Available | 2026-09-17 |
| Janssen Pharmaceuticals | 50458-587-01 | Concerta, Tablet, Extended Release, 54 mg (NDC 50458-587-01) | Available | 2026-09-17 |
| Lannett Company, Inc. | 62175-310-37 | Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 62175-310-37) | Available | 2026-10-01 |
| Lannett Company, Inc. | 62175-311-37 | Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 62175-311-37) | Unavailable | 2026-10-01 |
| Lannett Company, Inc. | 62175-312-37 | Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 62175-312-37) | Unavailable | 2026-10-01 |
| Lannett Company, Inc. | 62175-313-37 | Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 62175-313-37) | Available | 2026-10-01 |
| Sun Pharmaceutical Industries, Inc. | 57664-606-88 | Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 57664-606-88) | Unavailable | 2026-09-18 |
| Sun Pharmaceutical Industries, Inc. | 57664-607-88 | Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 57664-607-88) | Unavailable | 2026-09-18 |
| Sun Pharmaceutical Industries, Inc. | 57664-608-88 | Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 57664-608-88) | Unavailable | 2026-09-18 |
| Sun Pharmaceutical Industries, Inc. | 57664-609-88 | Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 57664-609-88) | Unavailable | 2026-09-18 |
| Teva Pharmaceuticals USA, Inc. | 62037-725-01 | Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 62037-725-01) | Limited Availability | 2026-10-01 |
| Teva Pharmaceuticals USA, Inc. | 62037-734-01 | Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 62037-734-01) | Available | 2026-10-01 |
| Teva Pharmaceuticals USA, Inc. | 62037-726-01 | Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 62037-726-01) | Limited Availability | 2026-10-01 |
| Teva Pharmaceuticals USA, Inc. | 62037-727-01 | Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 62037-727-01) | Available | 2026-10-01 |
| Trigen Laboratories, LLC | 13811-706-10 | Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 13811-706-10) | Limited Availability | 2026-10-01 |
| Trigen Laboratories, LLC | 13811-707-10 | Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 13811-707-10) | Limited Availability | 2026-10-01 |
| Trigen Laboratories, LLC | 13811-708-10 | Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 13811-708-10) | Limited Availability | 2026-10-01 |
| Trigen Laboratories, LLC | 13811-711-30 | Methylphenidate Hydrochloride, Tablet, Extended Release, 45 mg (NDC 13811-711-30) | Limited Availability | 2026-10-01 |
| Trigen Laboratories, LLC | 13811-709-10 | Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 13811-709-10) | Limited Availability | 2026-10-01 |
| Trigen Laboratories, LLC | 13811-700-30 | Methylphenidate Hydrochloride, Tablet, Extended Release, 63 mg (NDC 13811-700-30) | Limited Availability | 2026-10-01 |
| Trigen Laboratories, LLC | 13811-710-30 | Methylphenidate Hydrochloride, Tablet, Extended Release, 72 mg (NDC 13811-710-30) | Limited Availability | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-095-10 | Relexxii, Tablet, Extended Release, 18 mg (NDC 68025-095-10) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-095-30 | Relexxii, Tablet, Extended Release, 18 mg (NDC 68025-095-30) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-096-10 | Relexxii, Tablet, Extended Release, 27 mg (NDC 68025-096-10) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-096-30 | Relexxii, Tablet, Extended Release, 27 mg (NDC 68025-096-30) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-097-10 | Relexxii, Tablet, Extended Release, 36 mg (NDC 68025-097-10) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-097-30 | Relexxii, Tablet, Extended Release, 36 mg (NDC 68025-097-30) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-088-30 | Relexxii, Tablet, Extended Release, 45 mg (NDC 68025-088-30) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-098-10 | Relexxii, Tablet, Extended Release, 54 mg (NDC 68025-098-10) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-098-30 | Relexxii, Tablet, Extended Release, 54 mg (NDC 68025-098-30) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-089-30 | Relexxii, Tablet, Extended Release, 63 mg (NDC 68025-089-30) | Available | 2026-10-01 |
| Vertical Pharmaceuticals, LLC | 68025-084-30 | Relexxii, Tablet, Extended Release, 72 mg (NDC 68025-084-30) | Available | 2026-10-01 |
Source facts
Grouped generic ingredient: Methylphenidate Hydrochloride Tablet, Extended Release · 34 package records
Therapeutic categories: Psychiatry
Dosage forms: Tablet
Routes: ORAL
Open FDA source data · JSON · Markdown
FDA is authoritative. Source retrieved 2026-10-06T18:55:41+00:00. Derived grouping is documented in this record's derivations.