FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
52959-033
11-digit product format
529590033
Labeler code
52959
Product ID
52959-033_dda3a80a-8f5f-4502-ac2c-d4ac81fab9ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
52959-033-002020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-042020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-102020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-152020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-202020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-212020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-252020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-302020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-602020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-902020-01-31C16284748780-19d75b9d1-0d92-f424-e053-dadaa90a57ceMECLIZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-033-00MECLIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
52959-033-04MECLIZINE HYDROCHLORIDE4 in 1 BOTTLETABLET42
52959-033-10MECLIZINE HYDROCHLORIDE10 in 1 BOTTLETABLET102
52959-033-15MECLIZINE HYDROCHLORIDE15 in 1 BOTTLETABLET152
52959-033-20MECLIZINE HYDROCHLORIDE20 in 1 BOTTLETABLET202
52959-033-21MECLIZINE HYDROCHLORIDE21 in 1 BOTTLETABLET212
52959-033-25MECLIZINE HYDROCHLORIDE25 in 1 BOTTLETABLET252
52959-033-30MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET302
52959-033-60MECLIZINE HYDROCHLORIDE60 in 1 BOTTLETABLET602
52959-033-90MECLIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-033MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 10 package rows20120217_180aedec-8a48-4e56-8eed-7daff874161b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN180aedec-8a48-4e56-8eed-7daff874161b2
995666meclizine hydrochloride 25 MG Oral TabletSCD180aedec-8a48-4e56-8eed-7daff874161b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-033-0052959003300100 in 1 BOTTLEHistorical
52959-033-04529590033044 in 1 BOTTLEHistorical
52959-033-105295900331010 in 1 BOTTLEHistorical
52959-033-155295900331515 in 1 BOTTLEHistorical
52959-033-205295900332020 in 1 BOTTLEHistorical
52959-033-215295900332121 in 1 BOTTLEHistorical
52959-033-255295900332525 in 1 BOTTLEHistorical
52959-033-305295900333030 in 1 BOTTLEHistorical
52959-033-605295900336060 in 1 BOTTLEHistorical
52959-033-905295900339090 in 1 BOTTLEHistorical