FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
67296-2205
11-digit product format
672962205
Labeler code
67296
Product ID
67296-2205_510b342c-5716-a920-e063-6294a90a6235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA202640
Marketing category
ANDA
Marketing start
2023-09-14
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2205-2MECLIZINE HYDROCHLORIDE21 in 1 BOTTLETABLET212
67296-2205-3MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN4727e7a9-eabb-a2a7-e063-6394a90a87542
995666meclizine hydrochloride 25 MG Oral TabletSCD4727e7a9-eabb-a2a7-e063-6394a90a87542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2205-26729622050221 TABLET in 1 BOTTLE (67296-2205-2) 21 tablet2023-09-14NoNoHistorical
67296-2205-36729622050330 TABLET in 1 BOTTLE (67296-2205-3) 30 tablet2023-09-14NoNoHistorical