METHYLPHENIDATE HYDROCHLORIDE | N010187 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition form MD Pharmaceutical Inc. FDA-1992-P-0169 · 3 docket documents MD Pharmaceutical Inc., a generic drug manufacturer, filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.93 requesting that the FDA issue a finding that an abbreviated new drug application is suitable for Methylphenidate Hydrochloride Extende | Other | 2017-05-02 | Open | — |
Tedor Pharma Inc. - Citizen Petition FDA-2013-P-0303 · 4 docket documents Tedor Pharma Inc filed this citizen petition on March 6, 2013, pursuant to 21 CFR §314.161, requesting that the FDA determine whether UCB Inc's Metadate ER 10 mg (Methylphenidate Hydrochloride) Tablets (ANDA 040-306), which is listed as discontinued in the Orange Book, was voluntarily withdrawn for | Other | 2013-07-03 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.63
per ea
Lowest NADAC/Unit
$0.7974
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00078044105RITALIN 20 MG TABLET | $1.63 | EA | Brand | $0.2095 | 2026-06-17 |
| 66758027501RITALIN 20 MG TABLET | $1.63 | EA | Brand | $0.2095 | 2026-06-17 |
| 00078044005RITALIN 10 MG TABLET | $1.13 | EA | Brand | $0.1635 | 2026-06-17 |
| 66758027401RITALIN 10 MG TABLET | $1.13 | EA | Brand | $0.1635 | 2026-06-17 |
| 00078043905RITALIN 5 MG TABLET | $0.7974 | EA | Brand | $0.1344 | 2026-06-17 |
| 66758027301RITALIN 5 MG TABLET | $0.7974 | EA | Brand | $0.1344 | 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.