Meclizine Hydrochloride

Product NDC
71335-1825
11-digit product format
713351825
Labeler code
71335
Product ID
71335-1825_e1e6f9e4-9b01-4878-86ee-fc6c38b61932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-15
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

openFDA Listing Details

Product ID
71335-1825_e1e6f9e4-9b01-4878-86ee-fc6c38b61932
SPL ID
e1e6f9e4-9b01-4878-86ee-fc6c38b61932
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Meclizine Hydrochloride
Generic name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Marketing start
2020-01-15
Marketing category
NDA AUTHORIZED GENERIC
Application number
NDA010721
Pharmacologic classes
Antiemetic [EPC]; Emesis Suppression [PE]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiHDP7W44CIO
Rxcui995666
Spl Set Id27b6a7e0-a361-4705-9f31-719063a65f22
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-1825-014 TABLET in 1 BOTTLE (71335-1825-0)2022-02-24No
71335-1825-190 TABLET in 1 BOTTLE (71335-1825-1)2022-02-24No
71335-1825-230 TABLET in 1 BOTTLE (71335-1825-2)2022-02-24No
71335-1825-325 TABLET in 1 BOTTLE (71335-1825-3)2022-02-24No
71335-1825-420 TABLET in 1 BOTTLE (71335-1825-4)2022-02-24No
71335-1825-540 TABLET in 1 BOTTLE (71335-1825-5)2022-02-24No
71335-1825-660 TABLET in 1 BOTTLE (71335-1825-6)2022-02-24No
71335-1825-7120 TABLET in 1 BOTTLE (71335-1825-7)2022-02-24No
71335-1825-810 TABLET in 1 BOTTLE (71335-1825-8)2022-02-24No
71335-1825-9100 TABLET in 1 BOTTLE (71335-1825-9)2022-02-24No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
HDP7W44CIOMECLIZINE HYDROCHLORIDE31884-77-2MECLIZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1825-07133518250014 TABLET in 1 BOTTLE (71335-1825-0) 14 tablet2022-02-24NoNoHistorical
71335-1825-17133518250190 TABLET in 1 BOTTLE (71335-1825-1) 90 tablet2022-02-24NoNoHistorical
71335-1825-27133518250230 TABLET in 1 BOTTLE (71335-1825-2) 30 tablet2022-02-24NoNoHistorical
71335-1825-37133518250325 TABLET in 1 BOTTLE (71335-1825-3) 25 tablet2022-02-24NoNoHistorical
71335-1825-47133518250420 TABLET in 1 BOTTLE (71335-1825-4) 20 tablet2022-02-24NoNoHistorical
71335-1825-57133518250540 TABLET in 1 BOTTLE (71335-1825-5) 40 tablet2022-02-24NoNoHistorical
71335-1825-67133518250660 TABLET in 1 BOTTLE (71335-1825-6) 60 tablet2022-02-24NoNoHistorical
71335-1825-771335182507120 TABLET in 1 BOTTLE (71335-1825-7) 120 tablet2022-02-24NoNoHistorical
71335-1825-87133518250810 TABLET in 1 BOTTLE (71335-1825-8) 10 tablet2022-02-24NoNoHistorical
71335-1825-971335182509100 TABLET in 1 BOTTLE (71335-1825-9) 100 tablet2022-02-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meclizine HydrochlorideBryant Ranch Prepack2025-08-20HUMAN PRESCRIPTION DRUG LABEL102