FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
68071-2380
Requested package NDC
68071-2380-9
11-digit product format
680712380
Labeler code
68071
Product ID
68071-2380_4c0e9d87-bd8a-e85f-e063-6394a90aae17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-15
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010721-001ANTIVERTMECLIZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20
N010721-004ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982
N010721-005ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982
N010721-006ANTIVERTMECLIZINE HYDROCHLORIDE12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N010721-001AA
N010721-004AA
N010721-006AA

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
2026-08-01 22:54:322026-06N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20a50c72e98297…
2026-08-01 22:54:322026-06N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N010721-001AA1a50c72e98297…
2026-08-01 22:54:322026-06N010721-004AA1a50c72e98297…
2026-08-01 22:54:322026-06N010721-006AA1a50c72e98297…

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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyc6b3f4d8-5fcf-2278-e053-2a95a90ab1392026-06-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.d7d31433-8f39-4fe6-b542-1b4410122db72026-06-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack81e1762b-e012-4c6d-96e6-9a9f27a1880a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEREMEDYREPACK INC.21d4a6ee-0a66-45d7-bab9-c5eef399713d2026-05-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEREMEDYREPACK INC.d53bf04e-5cfc-4974-9b24-2cce545d1bd02026-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c31846b2-d47d-a97b-e053-2a95a90a9bec2026-03-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.beb36d86-9fb7-1f60-e053-2995a90aac132026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
ndc (package): 68071-2380-9
ndc (product): 68071-2380
ndc11 (package): 68071238009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack112103bc-25e2-42cf-8542-ba1d3392a2c32025-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack27b6a7e0-a361-4705-9f31-719063a65f222025-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERising Pharma Holdings, Inc.c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd2025-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2d31ae73-3f09-a77c-e063-6294a90ade9a2025-02-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRxd27fe828-4fee-3ba9-e053-2995a90ae7b62025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LP92e8390b-5173-4aa1-906d-35d2c0eaaaf62024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEDirect_Rxe79ecf77-0e0a-d7ef-e053-2a95a90a5adf2024-04-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAsclemed USA, Inc.e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db2024-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LPb91435d1-fb95-4939-8478-84e41f44f7322023-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995666Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
beb36d86-9fb7-1f60-e053-2995a90aac13Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNbeb36d86-9fb7-1f60-e053-2995a90aac132
995666meclizine hydrochloride 25 MG Oral TabletSCDbeb36d86-9fb7-1f60-e053-2995a90aac132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2380-96807123800990 TABLET in 1 BOTTLE (68071-2380-9) 90 tablet2021-03-290000-00-00NoNoCurrent