FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
0536-1299
11-digit product format
005361299
Labeler code
0536
Product ID
0536-1299_0eafa87d-ba74-5faa-e063-6294a90a79c1
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Rugby Laboratories
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-30
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995632

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
0536-1299-01Meclizine Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE1003
0536-1299-10Meclizine Hydrochloride1000 in 1 BOTTLETABLET, CHEWABLE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1299-10EA - Each0536-12994be88e27-d239-44c2-93e3-eb1867badd8212021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1299MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20240112_b57f14a7-3852-03db-e053-2a95a90a80d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNcd82fca9-a8dc-4545-8e64-b67d644832e7103
995632meclizine hydrochloride 25 MG Chewable TabletSCDcd82fca9-a8dc-4545-8e64-b67d644832e7103
995632meclizine HCl 25 MG Chewable TabletPSNf2390098-efb7-4cfb-879b-fe4524daf8869
995632meclizine hydrochloride 25 MG Chewable TabletSCDf2390098-efb7-4cfb-879b-fe4524daf8869
995632meclizine HCl 25 MG Chewable TabletPSNd0d8b376-8fe9-8776-e053-2a95a90ae6516
995632meclizine HCl 25 MG Chewable TabletPSN2518b0b6-35ab-49f4-936c-1eafea04b4666
995632meclizine HCl 25 MG Chewable TabletPSNa9ad5d27-306d-48ca-a10d-0a0415d08f056
995632meclizine hydrochloride 25 MG Chewable TabletSCDa9ad5d27-306d-48ca-a10d-0a0415d08f056
995632meclizine hydrochloride 25 MG Chewable TabletSCDd0d8b376-8fe9-8776-e053-2a95a90ae6516
995632meclizine hydrochloride 25 MG Chewable TabletSCD2518b0b6-35ab-49f4-936c-1eafea04b4666
995632meclizine HCl 25 MG Chewable TabletPSN54731aaf-d413-4976-b040-40c8e3e7eafd5
995632meclizine hydrochloride 25 MG Chewable TabletSCD54731aaf-d413-4976-b040-40c8e3e7eafd5
995632meclizine HCl 25 MG Chewable TabletPSNb57f14a7-3852-03db-e053-2a95a90a80d63
995632meclizine hydrochloride 25 MG Chewable TabletSCDb57f14a7-3852-03db-e053-2a95a90a80d63
995632meclizine HCl 25 MG Chewable TabletPSN199ae195-4556-ee88-e063-6394a90a40d42
995632meclizine hydrochloride 25 MG Chewable TabletSCD199ae195-4556-ee88-e063-6394a90a40d42
995632meclizine HCl 25 MG Chewable TabletPSNf41ea190-d73d-b8de-e053-2a95a90a076f1
995632meclizine HCl 25 MG Chewable TabletPSN0a10016e-3fca-476d-b815-fd2abd6019181
995632meclizine hydrochloride 25 MG Chewable TabletSCDf41ea190-d73d-b8de-e053-2a95a90a076f1
995632meclizine hydrochloride 25 MG Chewable TabletSCD0a10016e-3fca-476d-b815-fd2abd6019181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1299-0100536129901100 TABLET, CHEWABLE in 1 BOTTLE (0536-1299-01) 2020-10-300000-00-00NoNoCurrent
0536-1299-10005361299101000 TABLET, CHEWABLE in 1 BOTTLE (0536-1299-10) 2020-11-090000-00-00NoNoCurrent