FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
80136-779
Requested package NDC
80136-779-01
11-digit product format
801360779
Labeler code
80136
Product ID
80136-779_eea1e7ec-1ce0-02e3-e053-2a95a90aed44
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NORTHEAST PHARMA
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80136-77980136-779-01IInactivated by FDA2026-10-05

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
80136-779-01Meclizine Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-779MECLIZINE HYDROCHLORIDE (MECLIZINE HCL) TABLET, CHEWABLE [NORTHEAST PHARMA]2Legacy NDC, 1 package rows20231027_eea1e7ec-1cdf-02e3-e053-2a95a90aed44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNeea1e7ec-1cdf-02e3-e053-2a95a90aed442
995632meclizine hydrochloride 25 MG Chewable TabletSCDeea1e7ec-1cdf-02e3-e053-2a95a90aed442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80136-779-0180136077901100 TABLET, CHEWABLE in 1 BOTTLE (80136-779-01) 2022-11-010000-00-00NoNoCurrent