FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
71205-786
11-digit product format
712050786
Labeler code
71205
Product ID
71205-786_b91435d1-fb95-4939-8478-84e41f44f732
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995666

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-786-10Meclizine Hydrochloride10 in 1 BOTTLETABLET101
71205-786-20Meclizine Hydrochloride20 in 1 BOTTLETABLET201
71205-786-30Meclizine Hydrochloride30 in 1 BOTTLETABLET301
71205-786-60Meclizine Hydrochloride60 in 1 BOTTLETABLET601
71205-786-90Meclizine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-786MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 5 package rows20230408_b91435d1-fb95-4939-8478-84e41f44f732.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNb91435d1-fb95-4939-8478-84e41f44f7321
995666meclizine hydrochloride 25 MG Oral TabletSCDb91435d1-fb95-4939-8478-84e41f44f7321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-786-107120507861010 TABLET in 1 BOTTLE (71205-786-10) 10 tablet2023-04-03NoNoCurrent
71205-786-207120507862020 TABLET in 1 BOTTLE (71205-786-20) 20 tablet2023-04-03NoNoCurrent
71205-786-307120507863030 TABLET in 1 BOTTLE (71205-786-30) 30 tablet2023-04-03NoNoCurrent
71205-786-607120507866060 TABLET in 1 BOTTLE (71205-786-60) 60 tablet2023-04-03NoNoCurrent
71205-786-907120507869090 TABLET in 1 BOTTLE (71205-786-90) 90 tablet2023-04-03NoNoCurrent