MECLIZINE HYDROCHLORIDE

Product NDC
76420-130
11-digit product format
764200130
Labeler code
76420
Product ID
76420-130_b2ddcdd0-726a-99df-e053-2a95a90a8818
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 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
76420-130-107642001301010 TABLET in 1 BOTTLE (76420-130-10) 10 tablet2020-10-30NoNoHistorical
76420-130-207642001302020 TABLET in 1 BOTTLE (76420-130-20) 20 tablet2020-10-30NoNoHistorical
76420-130-307642001303030 TABLET in 1 BOTTLE (76420-130-30) 30 tablet2020-10-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MECLIZINE HYDROCHLORIDEAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2020-10-30HUMAN PRESCRIPTION DRUG LABEL1