DANTROLENE SODIUM | A076856 | IMPAX LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Elite Laboratories Inc FDA-2017-P-5954 · 6 docket documents Elite Laboratories, Inc. filed this petition under 21 CFR 314.122 requesting that the FDA determine Dantrolene Sodium 100 mg (ANDA 076856, manufactured by Impax Laboratories) is suitable as a Reference Listed Drug because the current Orange Book RLD, Dantrium 100 mg (Par Sterile Products LLC, NDA 17 | Other | 2017-09-27 | Denied | Elite Laboratories Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.8473
per ea
Lowest NADAC/Unit
$0.4539
per ea
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00115443301DANTROLENE SODIUM 100 MG CAP | $0.8473 | EA | Generic | — | 2026-06-17 |
| 00115442201DANTROLENE SODIUM 50 MG CAP | $0.5995 | EA | Generic | — | 2026-06-17 |
| 50268021715DANTROLENE SODIUM 25 MG CAP | $0.4539 | EA | Generic | — | 2026-06-17 |
| 68084030021DANTROLENE SODIUM 25 MG CAP | $0.4539 | EA | Generic | — | 2026-06-17 |
| 00115441101DANTROLENE SODIUM 25 MG CAP | $0.4539 | EA | Generic | — | 2026-06-17 |
| 00904721104DANTROLENE SODIUM 25 MG CAP | $0.4539 | 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.