Meclizine Hydrochloride

Product NDC
71205-647
11-digit product format
712050647
Labeler code
71205
Product ID
71205-647_bf1db485-1415-4229-b3e1-05a6f62ff7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-647-107120506471010 TABLET in 1 BOTTLE (71205-647-10) 10 tablet2022-03-23NoNoHistorical
71205-647-907120506479090 TABLET in 1 BOTTLE (71205-647-90) 90 tablet2022-03-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meclizine HydrochlorideProficient Rx LP2024-08-01HUMAN PRESCRIPTION DRUG LABEL2