MECLIZINE HYDROCHLORIDE | N010721 | CASPER PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceutical (USA) Inc FDA-2016-P-1667 · 6 docket documents Zydus Pharmaceuticals (USA) Inc. filed this citizen petition requesting that the FDA determine whether ANTIVERT (Meclizine Hydrochloride) Tablets, 12.5 mg and 25 mg approved under NDA 010721 by Casper Pharma LLC. was voluntarily withdrawn for safety or effectiveness reasons, and if not, to designate | 505(q) | 2016-06-16 | Partially Denied | Zydus Pharmaceutical (USA) Inc |
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2015-P-3400 · 5 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition requesting that FDA determine whether Citron Pharma LLC voluntarily withdrew, discontinued, or withheld from sale ANTIVERT (Meclizine Hydrochloride) Tablets in 12.5 mg, 25 mg, and 50 mg strengths under NDA 010721, and if so, whether generic ver | Other | 2015-09-23 | Denied | Lupin Pharmaceuticals, Inc. |
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 | — |
Cadila Pharmaceuticals Limited, India (Modavar Pharmaceuticals LLC) - Citizen... FDA-2012-P-0468 · 4 docket documents Cadila Pharmaceuticals Limited, a company based in India, filed this citizen petition on May 4, 2012, pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA designate PAR PHARM Meclizine Hydrochloride Tablets 12.5 mg and 25 mg as an alternate Reference Listed | 505(q) | 2012-05-10 | Partially Denied | — |
Lupin Pharmaceuticals, Inc. - Citizen Petition FDA-2012-P-0436 · 4 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition on May 3, 2012, requesting that the FDA amend the Orange Book to designate Par Pharms and Amneal Pharms as Reference Listed Drugs for Meclizine Hydrochloride Tablets at all three strengths (12.5 mg, 25 mg, and 50 mg), as these are the only two | Other | 2012-05-08 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.45
per ea
Lowest NADAC/Unit
$0.0464
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 16571066201MECLIZINE 50 MG TABLET | $2.45 | EA | Generic | — | 2026-06-17 |
| 16571066101MECLIZINE 25 MG TABLET | $0.0794 | EA | Generic | — | 2026-06-17 |
| 16571066110MECLIZINE 25 MG TABLET | $0.0794 | EA | Generic | — | 2026-06-17 |
| 16571066001MECLIZINE 12.5 MG TABLET | $0.0464 | EA | Generic | — | 2026-06-17 |
| 16571066050MECLIZINE 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.