METHYLPHENIDATE HYDROCHLORIDE | N021259 | AYTU BIOPHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Ascend Laboratories, LLC FDA-2018-P-2755 · 8 docket documents Ascend Laboratories, LLC filed this citizen petition on July 18, 2018, requesting that the FDA amend the Orange Book to designate any other approved generic version of Methylphenidate Hydrochloride Extended-Release Capsules (10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg) as an alternate reference sta | 505(q) | 2018-07-18 | Denied | Ascend Laboratories, LLC |
Citizen Petiton from Hyman, Phelps & McNamara, PC FDA-2018-P-2658 · 4 docket documents Hyman, Phelps & McNamara, PC filed this citizen petition requesting that FDA amend the Orange Book to designate ANDA 078873 as an additional reference standard for Methylphenidate Hydrochloride Capsules Extended Release 60 mg, because the current reference standard Metadate CD 60 mg (approved under | 505(q) | 2018-07-11 | Denied | — |
Citizen Petition request from ZYDUS Pharmaceuticals Inc FDA-2015-P-0720 · 6 docket documents Zydus Pharmaceuticals (USA), Inc. filed this citizen petition requesting that the FDA determine that the NDA-authorized generic Methylphenidate HCl Extended Release Capsules 60 mg (NDA 021259) marketed by Kremers Urban Pharmaceuticals Inc. is suitable as an alternate Reference Listed Drug for bioequ | Other | 2015-03-06 | Granted | — |
UCB, Inc. - Letter FDA-2004-P-0290 · 7 docket documents UCB, Inc. submitted general correspondence on June 23, 2011 regarding NDA 21-259 for Metadate CD (methylphenidate HCl, USP) extended-release capsules in strengths of 10 mg through 60 mg, providing updated regulatory contact information in response to an FDA request related to a prior citizen petitio | Other | 2011-07-18 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.81
per ea
Lowest NADAC/Unit
$1.05
per ea
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00527458137METHYLPHENIDATE CD 30 MG CAP | $1.81 | EA | Generic | — | 2026-06-17 |
| 00527458437METHYLPHENIDATE CD 60 MG CAP | $1.71 | EA | Generic | — | 2026-06-17 |
| 00527458337METHYLPHENIDATE CD 50 MG CAP | $1.50 | EA | Generic | — | 2026-06-17 |
| 00527458037METHYLPHENIDATE CD 20 MG CAP | $1.45 | EA | Generic | — | 2026-06-17 |
| 00527458237METHYLPHENIDATE CD 40 MG CAP | $1.42 | EA | Generic | — | 2026-06-17 |
| 00527457937METHYLPHENIDATE CD 10 MG CAP | $1.05 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.