Meclizine Hydrochloride

Product NDC
68071-3748
11-digit product format
680713748
Labeler code
68071
Product ID
68071-3748_352f1797-e850-efb9-e063-6294a90a6442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA213957
Marketing category
ANDA
Marketing start
2020-10-29
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 Hydrochloride
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3748-4Meclizine Hydrochloride4 in 1 BOTTLETABLET42
68071-3748-6Meclizine Hydrochloride6 in 1 BOTTLETABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3748MECLIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250516_2990e296-2d60-70c0-e063-6394a90abbe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN2990e296-2d60-70c0-e063-6394a90abbe42
995666meclizine hydrochloride 25 MG Oral TabletSCD2990e296-2d60-70c0-e063-6394a90abbe42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3748-4680713748044 TABLET in 1 BOTTLE (68071-3748-4) 4 tablet2025-05-15NoNoCurrent
68071-3748-6680713748066 TABLET in 1 BOTTLE (68071-3748-6) 6 tablet2024-12-18NoNoCurrent