FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
70518-1308
11-digit product format
705181308
Labeler code
70518
Product ID
70518-1308_51018185-a679-bf2c-e063-6394a90adca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040659
Marketing category
ANDA
Marketing start
2018-08-17
Marketing end
2026-10-31
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE

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
70518-1308-0MECLIZINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET9019
70518-1308-1MECLIZINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET3019
70518-1308-2MECLIZINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET6019
70518-1308-3MECLIZINE HYDROCHLORIDE21 in 1 BOTTLE, PLASTICTABLET2119
70518-1308-4MECLIZINE HYDROCHLORIDE6 in 1 BOTTLE, PLASTICTABLET619
70518-1308-5MECLIZINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1308MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 6 package rows20250510_ba2fb6de-af86-4c05-9018-135e1f8594f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNba2fb6de-af86-4c05-9018-135e1f8594f919
995666meclizine hydrochloride 25 MG Oral TabletSCDba2fb6de-af86-4c05-9018-135e1f8594f919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1308-07051813080090 TABLET in 1 BOTTLE, PLASTIC (70518-1308-0) 90 tablet2018-08-172026-10-31NoNoCurrent
70518-1308-17051813080130 TABLET in 1 BOTTLE, PLASTIC (70518-1308-1) 30 tablet2018-08-210000-00-00NoNoCurrent
70518-1308-27051813080260 in 1 BOTTLE, PLASTICHistorical
70518-1308-37051813080321 in 1 BOTTLE, PLASTICHistorical
70518-1308-4705181308046 in 1 BOTTLE, PLASTICHistorical
70518-1308-57051813080510 in 1 BOTTLE, PLASTICHistorical