MECLIZINE

Product NDC
16103-387
11-digit product format
161030387
Labeler code
16103
Product ID
16103-387_f25eaba1-2538-4b14-bc67-aa45e07b3014
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995632

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-387-082022-04-08C16284748780-1d6a99b39-eb8a-a426-e053-dadaa90af4c2Drug Facts
16103-387-112022-04-08C16284748780-1d6a99b39-eb8a-a426-e053-dadaa90af4c2Drug Facts
16103-387-082022-01-28C16284748780-1d6a99b39-eb8a-a426-e053-dadaa90af4c2Drug Facts
16103-387-112022-01-28C16284748780-1d6a99b39-eb8a-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-387-08MECLIZINE100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1004
16103-387-11MECLIZINE1000 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-387-08EA - Each16103-3873442d87d-ab37-4744-91ee-2186d8cf33ef12019-04-11
16103-387-11EA - Each16103-3875ff12391-bd24-4d54-bf8e-094ee2d6b49712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-387MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20250101_4bac2765-045c-405e-8006-8c5cfdfa89bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNcf79ac74-017e-4fb4-85d3-4ea944080e8914
995632meclizine hydrochloride 25 MG Chewable TabletSCDcf79ac74-017e-4fb4-85d3-4ea944080e8914
995632meclizine HCl 25 MG Chewable TabletPSN3a6b8c81-cfb8-4194-a9ad-ed0db19b72a94
995632meclizine HCl 25 MG Chewable TabletPSN4bac2765-045c-405e-8006-8c5cfdfa89bc4
995632meclizine hydrochloride 25 MG Chewable TabletSCD3a6b8c81-cfb8-4194-a9ad-ed0db19b72a94
995632meclizine hydrochloride 25 MG Chewable TabletSCD4bac2765-045c-405e-8006-8c5cfdfa89bc4
995632meclizine HCl 25 MG Chewable TabletPSN7575b02e-2659-4fc1-9fba-f2db53c09cd13
995632meclizine hydrochloride 25 MG Chewable TabletSCD7575b02e-2659-4fc1-9fba-f2db53c09cd13
995632meclizine HCl 25 MG Chewable TabletPSN1b2f80d7-cee3-1283-e063-6394a90abc4b2
995632meclizine hydrochloride 25 MG Chewable TabletSCD1b2f80d7-cee3-1283-e063-6394a90abc4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-387-0816103038708100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-387-08) 2018-02-010000-00-00NoNoCurrent
16103-387-11161030387111000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-387-11) 2018-02-010000-00-00NoNoCurrent