FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
51655-107
11-digit product format
516550107
Labeler code
51655
Product ID
51655-107_48c3b27e-acb4-6023-e063-6294a90ae95a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA040659
Marketing category
ANDA
Marketing start
2014-07-24
Marketing end
2026-10-31
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-107-522023-12-18C16284748780-19d75b9d0-9fc4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Rx Only Initial U.S. Approval: 1957
51655-107-522023-01-30C16284748780-19d75b9d0-9fc4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Rx Only Initial U.S. Approval: 1957
51655-107-522021-04-30C16284748780-19d75b9d0-9fc4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Rx Only Initial U.S. Approval: 1957
51655-107-522020-01-31C16284748780-19d75b9d0-9fc4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Rx Only Initial U.S. Approval: 1957

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-107-20MECLIZINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET205
51655-107-52MECLIZINE HYDROCHLORIDE30 in 1 BOTTLE, DISPENSINGTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-107MECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240110_c443873a-2e89-43b2-b145-dde3dadf7bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNc443873a-2e89-43b2-b145-dde3dadf7bc05
995666meclizine hydrochloride 25 MG Oral TabletSCDc443873a-2e89-43b2-b145-dde3dadf7bc05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-107-205165501072020 TABLET in 1 BOTTLE, PLASTIC (51655-107-20) 20 tablet2023-12-142026-10-31NoNoHistorical
51655-107-525165501075230 TABLET in 1 BOTTLE, DISPENSING (51655-107-52) 30 tablet2014-07-242026-10-31NoNoCurrent