FDA.reportPublic FDA data

NDC 68071-2380-09 - Meclizine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-2380
Requested NDC
68071-2380-09
Package NDCs from labels
68071-2380-2, 68071-2380-3, 68071-2380-9, 68071-2380-09
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Meclizine Hydrochloride - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-03-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2380-22023-01-30C16284748780-1f386c64a-09c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE. MECLIZINE hydrochloride tablets, for oral use MECLIZINE hydrochloride chewable tablets, for oral use Initial U.S. Approval: 1957
68071-2380-32023-01-30C16284748780-1f386c64a-09c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE. MECLIZINE hydrochloride tablets, for oral use MECLIZINE hydrochloride chewable tablets, for oral use Initial U.S. Approval: 1957
68071-2380-92023-01-30C16284748780-1f386c64a-09c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE. MECLIZINE hydrochloride tablets, for oral use MECLIZINE hydrochloride chewable tablets, for oral use Initial U.S. Approval: 1957

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2380-2Meclizine Hydrochloride20 in 1 BOTTLETABLET202
68071-2380-3Meclizine Hydrochloride30 in 1 BOTTLETABLET302
68071-2380-9Meclizine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2380MECLIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 3 package rows20210331_beb36d86-9fb7-1f60-e053-2995a90aac13.zip

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 20 · 382 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
MECLIZINE HYDROCHLORIDEMECLIZINEBryant Ranch Prepackdab43efd-bec6-472f-b13a-1c043914dcd12026-07-27Warnings, Adverse reactionsExact identifier
unii: HDP7W44CIO
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERugby Laboratoriesb57f14a7-3852-03db-e053-2a95a90a80d62026-07-16WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENorthwind Health Company, LLC1b541252-e8a7-b678-e063-6394a90a34dc2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Motion Sickness ReliefMECLIZINE HCLTopco Associates, LLC307e3144-3b01-4bd0-9155-6b58fc4cab922026-07-09WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEREMEDYREPACK INC.ba2fb6de-af86-4c05-9018-135e1f8594f92026-07-03Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
MECLIZINE HYDROCHLORIDEMECLIZINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b11c10b9-f40e-4ea7-9c5d-118517049f9d2026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 995686
unii: HDP7W44CIO
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyc6b3f4d8-5fcf-2278-e053-2a95a90ab1392026-06-21Warnings, Adverse reactionsExact identifier
application number: NDA010721
rxcui: 995666
unii: HDP7W44CIO
Motion Sickness ReliefMECLIZINE HCLCardinal Health 110, LLC. DBA Leader69099658-a584-49a9-8a95-de258a697c4f2026-06-16WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO