FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
16571-660
11-digit product format
165710660
Labeler code
16571
Product ID
16571-660_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
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-660-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1003
16571-660-50Meclizine Hydrochloride500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-660-01EA - Each16571-660b658cb36-5fc1-4dc9-b22c-279032cf700112020-06-05
16571-660-50EA - Each16571-6603e8e6613-79c6-4219-9a1f-e1a7d7fd74ad12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-660MECLIZINE 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
995624meclizine HCl 12.5 MG Oral TabletPSN112103bc-25e2-42cf-8542-ba1d3392a2c3103
995624meclizine hydrochloride 12.5 MG Oral TabletSCD112103bc-25e2-42cf-8542-ba1d3392a2c3103
995624meclizine HCl 12.5 MG Oral TabletPSNd53bf04e-5cfc-4974-9b24-2cce545d1bd04
995624meclizine hydrochloride 12.5 MG Oral TabletSCDd53bf04e-5cfc-4974-9b24-2cce545d1bd04
995624meclizine HCl 12.5 MG Oral TabletPSNd27fe828-4fee-3ba9-e053-2995a90ae7b63
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
995624meclizine hydrochloride 12.5 MG Oral TabletSCDd27fe828-4fee-3ba9-e053-2995a90ae7b63
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
995624meclizine HCl 12.5 MG Oral TabletPSN92e8390b-5173-4aa1-906d-35d2c0eaaaf62
995624meclizine HCl 12.5 MG Oral TabletPSNd7d31433-8f39-4fe6-b542-1b4410122db72
995624meclizine hydrochloride 12.5 MG Oral TabletSCD92e8390b-5173-4aa1-906d-35d2c0eaaaf62
995624meclizine hydrochloride 12.5 MG Oral TabletSCDd7d31433-8f39-4fe6-b542-1b4410122db72
995624meclizine HCl 12.5 MG Oral TabletPSNe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
995666meclizine HCl 25 MG Oral TabletPSNe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
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 TabletSCDe6a5df4b-5cbf-4a0c-b38a-f4509c9c17db1
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
16571-660-0116571066001100 TABLET in 1 BOTTLE (16571-660-01) 100 tablet2020-01-150000-00-00NoNoCurrent
16571-660-5016571066050500 TABLET in 1 BOTTLE (16571-660-50) 500 tablet2020-01-150000-00-00NoNoCurrent