MECLIZINE HYDROCHLORIDE | A040659 | JUBILANT CADISTA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Indicus Pharma LLC - Citzen Petition FDA-2012-P-1265 · 4 docket documents Indicus Pharma LLC filed this citizen petition on December 17, 2012, requesting that the FDA amend the Orange Book to designate Mylan Pharms Inc, Par Pharm, and Amneal Pharms as additional reference listed drugs for Meclizine Hydrochloride tablets in all three strengths (12.5 mg, 25 mg, and 50 mg), | 505(q) | 2012-12-31 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0464
per ea
Lowest NADAC/Unit
$0.0464
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59746012206MECLIZINE 12.5 MG TABLET | $0.0464 | EA | Generic | — | 2026-06-17 |
| 59746012210MECLIZINE 12.5 MG TABLET | $0.0464 | 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.