FDA.reportPublic FDA data

Application 087127

Type
ANDA
Sponsor
AUREX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2020-11-12 02:37 UTC2020-11A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 1982ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A087127-001AA174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A087127-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087127-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087127-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087127-001AA1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINE HYDROCHLORIDEMECLIZINEA-S Medication Solutions55e262d9-d9dd-43a3-bc74-35e46dd391be2024-10-30Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDEMECLIZINEA-S Medication Solutions949f7347-8c3a-43ce-b975-8d187096f09f2024-10-30Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
DRAMAMINE - NMECLIZINE HYDROCHLORIDEMedtech Products Inc.7fec7791-c242-4e43-8184-32820e657afb2024-10-25WarningsName fallback
generic name: MECLIZINE HYDROCHLORIDE
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.f8cf751a-9f19-4744-a350-cd22303435ee2024-10-25WarningsName fallback
generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDEMECLIZINENCS HealthCare of KY, LLC dba Vangard Labs1a33dec1-8d59-48bd-aaef-77d162194d572024-08-08Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LP92e8390b-5173-4aa1-906d-35d2c0eaaaf62024-08-01Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDENuCare Pharmaceuticals,Inc.64a508ae-768a-2fba-e053-2991aa0ac42d2024-07-17Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC199ae195-4556-ee88-e063-6394a90a40d42024-06-10WarningsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEDirect_Rxe79ecf77-0e0a-d7ef-e053-2a95a90a5adf2024-04-09Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAsclemed USA, Inc.e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db2024-04-08Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.947a03c5-bca0-4d97-90b9-bcd6d65882732024-03-22Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutionseae4bc73-fee1-4831-b31c-8ca56fb83ad72023-12-03Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsName fallback
generic name: MECLIZINE HYDROCHLORIDE
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsName fallback
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINEAmneal Pharmaceuticals LLC666dc4d8-7b16-4c3c-84e4-645548dbee682023-09-28Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDEMECLIZINEAurobindo Pharma Limitedbeb3c7f2-c0f4-41d9-a903-63a6847e09972023-09-15Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEZydus Lifesciences Limitedcf157a71-f80a-4fb7-b892-7102b65a8ec02023-08-28Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions51c96c7a-0a38-41a5-a6c9-7f45db65fdda2023-04-19Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LPb91435d1-fb95-4939-8478-84e41f44f7322023-04-01Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEProficient Rx LP6a8cbc12-0725-4462-bb71-0b18cefc19e72023-01-01Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
generic name: MECLIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1553Meclizine Hydrochloridemeclizine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-383Meclizine HydrochlorideMeclizine HydrochlorideRebel Distributors Corp.ANDACurrent
49884-034Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-034Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
52959-225Meclizine Hydrochloridemeclizine hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
60429-204Meclizine Hydrochloridemeclizine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent