Meclizine Hydrochloride

Product NDC
76420-797
11-digit product format
764200797
Labeler code
76420
Product ID
76420-797_158f70ad-1608-c116-e063-6394a90a94c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-15
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
HDP7W44CIOMECLIZINE HYDROCHLORIDE31884-77-2MECLIZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-797-0176420079701100 TABLET in 1 BOTTLE (76420-797-01) 100 tablet2024-04-05NoNoHistorical
76420-797-307642007973030 TABLET in 1 BOTTLE (76420-797-30) 30 tablet2024-04-05NoNoHistorical
76420-797-607642007976060 TABLET in 1 BOTTLE (76420-797-60) 60 tablet2024-04-05NoNoHistorical
76420-797-907642007979090 TABLET in 1 BOTTLE (76420-797-90) 90 tablet2024-04-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meclizine HydrochlorideAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-04-08HUMAN PRESCRIPTION DRUG LABEL1