MECLIZINE

Product NDC
0536-1297
11-digit product format
005361297
Labeler code
0536
Product ID
0536-1297_e35b2d6b-c702-4a55-a4bb-929b8a40012f
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 12.5 mg
Dosage form
TABLET
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-21
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
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
0536-1297-01MECLIZINE100 in 1 BOTTLE, PLASTICTABLET1004
0536-1297-10MECLIZINE1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1297-10EA - Each0536-1297b75e79a5-13b3-4cee-92ac-f0d9e67247ad12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1297MECLIZINE (MECLIZINE HCL 12.5 MG) TABLET [RUGBY LABORATORIES]4Current NDC, Legacy NDC, 2 package rows20241222_8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN8a234ce3-eb6b-49dd-9d78-7fc7bdd49d354
995624meclizine hydrochloride 12.5 MG Oral TabletSCD8a234ce3-eb6b-49dd-9d78-7fc7bdd49d354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1297-0100536129701100 TABLET in 1 BOTTLE, PLASTIC (0536-1297-01) 100 tablet2020-05-210000-00-00NoNoCurrent
0536-1297-10005361297101000 TABLET in 1 BOTTLE, PLASTIC (0536-1297-10) 1000 tablet2020-05-210000-00-00NoNoCurrent