Meclizine Hydrochloride

Product NDC
62135-954
11-digit product format
621350954
Labeler code
62135
Product ID
62135-954_30511729-d20f-8726-e063-6394a90a6053
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA203003
Marketing category
ANDA
Marketing start
2022-08-11
Substance
MECLIZINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624, 995666, 995686

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
62135-954-60Meclizine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-954-60EA - Each62135-9544f58e462-e5c4-4cfa-b9c7-a3ae7670c9a112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-954MECLIZINE HYDROCHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC]3Current NDC, 1 package rows20250321_87d4c6d8-9218-48c2-9163-615a32449f11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN87d4c6d8-9218-48c2-9163-615a32449f113
995666meclizine HCl 25 MG Oral TabletPSN87d4c6d8-9218-48c2-9163-615a32449f113
995686meclizine HCl 50 MG Oral TabletPSN87d4c6d8-9218-48c2-9163-615a32449f113
995624meclizine hydrochloride 12.5 MG Oral TabletSCD87d4c6d8-9218-48c2-9163-615a32449f113
995666meclizine hydrochloride 25 MG Oral TabletSCD87d4c6d8-9218-48c2-9163-615a32449f113
995686meclizine hydrochloride 50 MG Oral TabletSCD87d4c6d8-9218-48c2-9163-615a32449f113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-954-606213509546060 TABLET, FILM COATED in 1 BOTTLE (62135-954-60) 2025-03-04NoNoHistorical