MECLIZINE

Product NDC
61919-301
11-digit product format
619190301
Labeler code
61919
Product ID
61919-301_9c98d740-5c42-292b-e053-2a95a90ac1c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA200294
Marketing category
ANDA
Marketing start
2016-04-28
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-301-302023-01-30C16284748780-1f386c64a-1816-0266-e053-dadaa90a7c1aMECLIZINE HYDROCHLORIDE 12.5mg 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-301-30MECLIZINE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-301-30EA - Each61919-3014be79cb0-9b92-468e-9bf0-03021047b10612016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-301MECLIZINE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20200130_3218d48a-aa80-0105-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN3218d48a-aa80-0105-e054-00144ff88e882
995624meclizine hydrochloride 12.5 MG Oral TabletSCD3218d48a-aa80-0105-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-301-306191903013030 TABLET in 1 BOTTLE (61919-301-30) 30 tablet2016-04-280000-00-00NoNoCurrent