FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
68071-2380
11-digit product format
680712380
Labeler code
68071
Product ID
68071-2380_4c0e9d87-bd8a-e85f-e063-6394a90aae17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-15
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995666

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
68071-2380-22023-01-30C16284748780-1f386c64a-09c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE. MECLIZINE hydrochloride tablets, for oral use MECLIZINE hydrochloride chewable tablets, for oral use Initial U.S. Approval: 1957
68071-2380-32023-01-30C16284748780-1f386c64a-09c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE. MECLIZINE hydrochloride tablets, for oral use MECLIZINE hydrochloride chewable tablets, for oral use Initial U.S. Approval: 1957
68071-2380-92023-01-30C16284748780-1f386c64a-09c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE. MECLIZINE hydrochloride tablets, for oral use MECLIZINE hydrochloride chewable tablets, for oral use Initial U.S. Approval: 1957

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2380-2Meclizine Hydrochloride20 in 1 BOTTLETABLET202
68071-2380-3Meclizine Hydrochloride30 in 1 BOTTLETABLET302
68071-2380-9Meclizine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2380MECLIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 3 package rows20210331_beb36d86-9fb7-1f60-e053-2995a90aac13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNbeb36d86-9fb7-1f60-e053-2995a90aac132
995666meclizine hydrochloride 25 MG Oral TabletSCDbeb36d86-9fb7-1f60-e053-2995a90aac132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2380-26807123800220 TABLET in 1 BOTTLE (68071-2380-2) 20 tablet2021-03-290000-00-00NoNoCurrent
68071-2380-36807123800330 TABLET in 1 BOTTLE (68071-2380-3) 30 tablet2021-03-290000-00-00NoNoCurrent
68071-2380-96807123800990 TABLET in 1 BOTTLE (68071-2380-9) 90 tablet2021-03-290000-00-00NoNoCurrent