FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
68788-7873
Requested package NDC
68788-7873-1
11-digit product format
687887873
Labeler code
68788
Product ID
68788-7873_b628c270-e2e7-4398-934b-504d9b16a8fa
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-02-19
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 packagepackage68788-787368788-7873-1DDiscontinued by firm2026-10-12

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
68788-7873-1Meclizine Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE1005
68788-7873-2Meclizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE305
68788-7873-3Meclizine Hydrochloride1000 in 1 BOTTLETABLET, CHEWABLE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7873-1EA - Each68788-78735b583c2a-f505-4533-9c29-7de8bac5387e12022-09-12
68788-7873-3EA - Each68788-7873f634644e-d615-4282-9f21-525ecf1858d712022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7873MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC, 3 package rows20240704_54731aaf-d413-4976-b040-40c8e3e7eafd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN54731aaf-d413-4976-b040-40c8e3e7eafd5
995632meclizine hydrochloride 25 MG Chewable TabletSCD54731aaf-d413-4976-b040-40c8e3e7eafd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7873-168788787301100 TABLET, CHEWABLE in 1 BOTTLE (68788-7873-1) 2021-02-190000-00-00NoNoCurrent