FDA Orange Book · active-ingredient family
Meclizine hydrochloride
Meclizine hydrochloride: 1 brand, 37 generics; first approved Jan 04, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 37 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
37
Listed patents
0
Presentations
57
Brand (NDA) products
Originator applications
- CASPER PHARMA LLCNDA 010721—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 25MG TABLET, CHEWABLE ORAL Rx — 12.5MG TABLET ORAL Rx AA
Generic (ANDA) products (37)
Abbreviated applications
- MECLIZINE HYDROCHLORIDECHARTWELL RXANDA 20300320223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDEINVAGEN PHARMSANDA 2007912022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, CHEWABLE ORAL Discontinued — - MECLIZINE HYDROCHLORIDEINVAGEN PHARMSANDA 20043220223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEZYDUS LIFESCIENCESANDA 21395720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDEHERITAGEANDA 20513620193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDEAUROBINDO PHARMA USAANDA 20264020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDEEPIC PHARMA LLCANDA 20029420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDERSAMNEAL PHARMSANDA 20145120113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA 50MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDEJUBILANT CADISTAANDA 04065920102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AA 25MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDERISINGANDA 04017919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEQUAGENANDA 0840921989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDESANDOZANDA 0848431989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 0896741988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEPLIVAANDA 0887331985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, CHEWABLE ORAL Discontinued — - MECLIZINE HYDROCHLORIDEANI PHARMSANDA 0887321985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEPLIVAANDA 0887341985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDESUPERPHARMANDA 0891131985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDESUPERPHARMANDA 0891141985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEUDLANDA 0882561983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEUDLANDA 0882571983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEVANGARDANDA 0878771982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEVANGARDANDA 0876201982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084976—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, CHEWABLE ORAL Discontinued — - MECLIZINE HYDROCHLORIDENEXGEN PHARMA INCANDA 086392—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, CHEWABLE ORAL Discontinued — - MECLIZINE HYDROCHLORIDEABC HOLDINGANDA 085253—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEABC HOLDINGANDA 085252—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEANABOLICANDA 085891—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEANI PHARMSANDA 084657—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEANI PHARMSANDA 085269—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEANI PHARMSANDA 085740—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEBUNDYANDA 084382—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEBUNDYANDA 084872—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083784—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEKV PHARMANDA 085524—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDEKV PHARMANDA 085523—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MECLIZINE HYDROCHLORIDESENORES PHARMSANDA 087128—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AA 12.5MG TABLET ORAL Rx AA - MECLIZINE HYDROCHLORIDEWATSON LABSANDA 085195—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 5 mo ago
Most recent approval
4 yr 3 mo ago
Approvals span 1982–2022 across 38 FDA applications.
Brand (NDA) 13%
Generic (ANDA) 3797%
Meclizine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
