FDA.reportPublic FDA data

MECLIZINE

Product NDC
16103-386
11-digit product format
161030386
Labeler code
16103
Product ID
16103-386_d7d81436-c338-4988-bf9e-a721e0cb8f91
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 12.5 mg
Dosage form
TABLET
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 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 HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624

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
16103-386-082024-12-31C16284748780-1d6a99b39-35a2-a426-e053-dadaa90af4c2Drug Facts
16103-386-112024-12-31C16284748780-1d6a99b39-35a2-a426-e053-dadaa90af4c2Drug Facts
16103-386-082022-01-28C16284748780-1d6a99b39-35a2-a426-e053-dadaa90af4c2Drug Facts
16103-386-112022-01-28C16284748780-1d6a99b39-35a2-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-386-08MECLIZINE100 in 1 BOTTLE, PLASTICTABLET1003
16103-386-11MECLIZINE1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-386-08EA - Each16103-3862154668d-662d-47cf-bbf1-5bb5c63c750d12019-04-11
16103-386-11EA - Each16103-38651f253cb-57da-41ee-bc3e-9f303e042a0e12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-386MECLIZINE (MECLIZINE HCL 12.5 MG) TABLET [PHARBEST PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20250101_8b3c9283-b618-4d57-9f15-7cf73e8737f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN8b3c9283-b618-4d57-9f15-7cf73e8737f53
995624meclizine HCl 12.5 MG Oral TabletPSN99b87792-f0b8-458f-9316-0d0c9e1d16843
995624meclizine hydrochloride 12.5 MG Oral TabletSCD8b3c9283-b618-4d57-9f15-7cf73e8737f53
995624meclizine hydrochloride 12.5 MG Oral TabletSCD99b87792-f0b8-458f-9316-0d0c9e1d16843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-386-0816103038608100 TABLET in 1 BOTTLE, PLASTIC (16103-386-08) 100 tablet2018-02-010000-00-00NoNoCurrent
16103-386-11161030386111000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11) 1000 tablet2018-02-010000-00-00NoNoCurrent