MECLIZINE HYDROCHLORIDE

Product NDC
71205-416
11-digit product format
712050416
Labeler code
71205
Product ID
71205-416_9feb2d58-035e-458e-a184-3c27d8a66df6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
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
71205-416-107120504161010 TABLET in 1 BOTTLE (71205-416-10) 10 tablet2020-03-03NoNoHistorical
71205-416-307120504163030 TABLET in 1 BOTTLE (71205-416-30) 30 tablet2020-03-03NoNoHistorical
71205-416-607120504166060 TABLET in 1 BOTTLE (71205-416-60) 60 tablet2020-03-03NoNoHistorical
71205-416-907120504169090 TABLET in 1 BOTTLE (71205-416-90) 90 tablet2020-03-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MECLIZINE HYDROCHLORIDEProficient Rx LP2023-01-01HUMAN PRESCRIPTION DRUG LABEL2