Meclizine Hydrochloride

Product NDC
68071-3791
11-digit product format
680713791
Labeler code
68071
Product ID
68071-3791_2e0ed208-075d-a301-e063-6294a90a84e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA213957
Marketing category
ANDA
Marketing start
2020-10-29
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
68071-3791-26807137910220 TABLET in 1 BOTTLE (68071-3791-2) 20 tablet2025-02-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meclizine HydrochlorideNuCare Pharmaceuticals, Inc.2025-02-13HUMAN PRESCRIPTION DRUG LABEL1