Meclizine Hydrochloride

Product NDC
53808-0380
11-digit product format
538080380
Labeler code
53808
Product ID
53808-0380_00973f5a-1447-4002-a86a-e2b61fad3678
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA087128
Marketing category
ANDA
Marketing start
2009-07-01
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
2017-12-31
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
53808-0380-12019-10-21C16284748780-1956f9ecf-d821-621f-e053-dbdaa90a74ade6aa2220-2ef7-41d0-870d-e898ebcb4e7f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0380-1Meclizine Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0380MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_e6aa2220-2ef7-41d0-870d-e898ebcb4e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNe6aa2220-2ef7-41d0-870d-e898ebcb4e7f1
995666meclizine hydrochloride 25 MG Oral TabletSCDe6aa2220-2ef7-41d0-870d-e898ebcb4e7f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0380-15380803800130 in 1 BLISTER PACKHistorical