FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
71205-416
11-digit product format
712050416
Labeler code
71205
Product ID
71205-416_9feb2d58-035e-458e-a184-3c27d8a66df6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
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 HYDROCHLORIDE
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-416-10MECLIZINE HYDROCHLORIDE10 in 1 BOTTLETABLET102
71205-416-30MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET302
71205-416-60MECLIZINE HYDROCHLORIDE60 in 1 BOTTLETABLET602
71205-416-90MECLIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-416-10EA - Each71205-416aabc6068-ccd6-4f34-ad95-107422d6641012020-05-08
71205-416-90EA - Each71205-4165e978e24-6594-4da1-bab1-bf3591f688e912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-416MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20230115_6a8cbc12-0725-4462-bb71-0b18cefc19e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN6a8cbc12-0725-4462-bb71-0b18cefc19e72
995624meclizine hydrochloride 12.5 MG Oral TabletSCD6a8cbc12-0725-4462-bb71-0b18cefc19e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-416-107120504161010 TABLET in 1 BOTTLE (71205-416-10) 10 tablet2020-03-030000-00-00NoNoCurrent
71205-416-307120504163030 TABLET in 1 BOTTLE (71205-416-30) 30 tablet2020-03-030000-00-00NoNoCurrent
71205-416-607120504166060 TABLET in 1 BOTTLE (71205-416-60) 60 tablet2020-03-030000-00-00NoNoCurrent
71205-416-907120504169090 TABLET in 1 BOTTLE (71205-416-90) 90 tablet2020-03-030000-00-00NoNoCurrent