FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
16571-661
11-digit product format
165710661
Labeler code
16571
Product ID
16571-661_2be27ea6-3d0a-4036-ab42-fea4720daa34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-15
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
Rxcui995624, 995632, 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
16571-661-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1003
16571-661-10Meclizine Hydrochloride1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-661-01EA - Each16571-66114a077b1-2415-40fa-8d04-4eeea8c223f512020-06-05
16571-661-10EA - Each16571-661ca25aced-13da-42da-a237-e6775da3eaaf12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-661MECLIZINE HYDROCHLORIDE TABLET MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [RISING PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20221023_c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN27b6a7e0-a361-4705-9f31-719063a65f22102
995666meclizine hydrochloride 25 MG Oral TabletSCD27b6a7e0-a361-4705-9f31-719063a65f22102
995666meclizine HCl 25 MG Oral TabletPSN21d4a6ee-0a66-45d7-bab9-c5eef399713d9
995666meclizine hydrochloride 25 MG Oral TabletSCD21d4a6ee-0a66-45d7-bab9-c5eef399713d9
995666meclizine HCl 25 MG Oral TabletPSNbe620ef8-5391-5b60-e053-2a95a90a0aa45
995666meclizine hydrochloride 25 MG Oral TabletSCDbe620ef8-5391-5b60-e053-2a95a90a0aa45
995666meclizine HCl 25 MG Oral TabletPSNe79ecf77-0e0a-d7ef-e053-2a95a90a5adf4
995666meclizine HCl 25 MG Oral TabletPSNc6b3f4d8-5fcf-2278-e053-2a95a90ab1394
995666meclizine hydrochloride 25 MG Oral TabletSCDe79ecf77-0e0a-d7ef-e053-2a95a90a5adf4
995666meclizine hydrochloride 25 MG Oral TabletSCDc6b3f4d8-5fcf-2278-e053-2a95a90ab1394
995624meclizine HCl 12.5 MG Oral TabletPSNc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995632meclizine HCl 25 MG Chewable TabletPSNc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995666meclizine HCl 25 MG Oral TabletPSNc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995686meclizine HCl 50 MG Oral TabletPSNc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995624meclizine hydrochloride 12.5 MG Oral TabletSCDc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995632meclizine hydrochloride 25 MG Chewable TabletSCDc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995666meclizine hydrochloride 25 MG Oral TabletSCDc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995686meclizine hydrochloride 50 MG Oral TabletSCDc9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd3
995666meclizine HCl 25 MG Oral TabletPSNbeb36d86-9fb7-1f60-e053-2995a90aac132
995666meclizine HCl 25 MG Oral TabletPSNc31846b2-d47d-a97b-e053-2a95a90a9bec2
995666meclizine hydrochloride 25 MG Oral TabletSCDc31846b2-d47d-a97b-e053-2a95a90a9bec2
995666meclizine hydrochloride 25 MG Oral TabletSCDbeb36d86-9fb7-1f60-e053-2995a90aac132
995624meclizine HCl 12.5 MG Oral TabletPSNe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
995666meclizine HCl 25 MG Oral TabletPSNb91435d1-fb95-4939-8478-84e41f44f7321
995666meclizine HCl 25 MG Oral TabletPSNe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
995666meclizine HCl 25 MG Oral TabletPSN2d31ae73-3f09-a77c-e063-6294a90ade9a1
995686meclizine HCl 50 MG Oral TabletPSNe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
995624meclizine hydrochloride 12.5 MG Oral TabletSCDe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
995666meclizine hydrochloride 25 MG Oral TabletSCDb91435d1-fb95-4939-8478-84e41f44f7321
995666meclizine hydrochloride 25 MG Oral TabletSCDe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
995666meclizine hydrochloride 25 MG Oral TabletSCD2d31ae73-3f09-a77c-e063-6294a90ade9a1
995686meclizine hydrochloride 50 MG Oral TabletSCDe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-661-0116571066101100 TABLET in 1 BOTTLE (16571-661-01) 100 tablet2020-01-150000-00-00NoNoCurrent
16571-661-10165710661101000 TABLET in 1 BOTTLE (16571-661-10) 1000 tablet2020-01-150000-00-00NoNoCurrent