MEXILETINE HYDROCHLORIDE | A074377 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2023-P-2157 · 4 docket documents Rising Pharma Holdings, Inc. submitted a suitability petition on May 26, 2023, requesting approval to file an Abbreviated New Drug Application for Mexiletine Hydrochloride Capsules USP at a new 300 mg strength, which differs from the reference listed drug MEXITIL capsules at 150 mg, 200 mg, and 250 | Suitability | 2023-05-26 | Granted | Rising Pharma Holdings, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4464
per ea
Lowest NADAC/Unit
$0.2387
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093874101MEXILETINE 250 MG CAPSULE | $0.4464 | EA | Generic | — | 2026-06-17 |
| 00093874001MEXILETINE 200 MG CAPSULE | $0.2651 | EA | Generic | — | 2026-06-17 |
| 00093873901MEXILETINE 150 MG CAPSULE | $0.2387 | 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.