MECLIZINE HYDROCHLORIDE

Product NDC
50090-7416
11-digit product format
500907416
Labeler code
50090
Product ID
50090-7416_5c051561-d0cd-47ac-a5c4-b059d3db83b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202640
Marketing category
ANDA
Marketing start
2023-09-14
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
3L5TQ84570MECLIZINE569-65-3MECLIZINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7416-25009074160212 TABLET in 1 BOTTLE (50090-7416-2) 12 tablet2024-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MECLIZINE HYDROCHLORIDEA-S Medication Solutions2024-10-30Human Prescription Drug Label1