FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
80136-378
11-digit product format
801360378
Labeler code
80136
Product ID
80136-378_e3c73fdc-670e-118f-e053-2a95a90a954c
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
NORTHEAST PHARMA
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-01
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80136-378IInactivated by FDA2026-10-12
excluded packagepackage80136-37880136-378-01IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80136-378-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-378MECLIZINE HYDROCHLORIDE (MECLIZINE HCL) TABLET [NORTHEAST PHARMA]2Legacy NDC, 1 package rows20231115_e3c73fdc-670d-118f-e053-2a95a90a954c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNe3c73fdc-670d-118f-e053-2a95a90a954c2
995666meclizine hydrochloride 25 MG Oral TabletSCDe3c73fdc-670d-118f-e053-2a95a90a954c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80136-378-0180136037801100 TABLET in 1 BOTTLE (80136-378-01) 100 tablet2022-05-010000-00-00NoNoCurrent