FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
42806-014
11-digit product format
428060014
Labeler code
42806
Product ID
42806-014_42600718-075b-481b-8fec-cb6cbadab7de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma LLC
Application
ANDA200294
Marketing category
ANDA
Marketing start
2012-04-30
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
Rxcui995624, 995666

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
42806-014-01Meclizine Hydrochloride100 in 1 BOTTLETABLET10012
42806-014-10Meclizine Hydrochloride1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-014-01EA - Each42806-01439e3abf0-a8ed-48cd-adda-055ff3a69abc12014-06-03
42806-014-10EA - Each42806-014d6508398-c136-4cae-bf86-3d1422d202c312014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]6
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]6
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [DIRECTRX]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [DIRECTRX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-014MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA LLC]12Current NDC, Legacy NDC, 2 package rows20200822_467e464b-bbaf-4053-9136-39e47a92fa05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN467e464b-bbaf-4053-9136-39e47a92fa0512
995666meclizine HCl 25 MG Oral TabletPSN467e464b-bbaf-4053-9136-39e47a92fa0512
995624meclizine hydrochloride 12.5 MG Oral TabletSCD467e464b-bbaf-4053-9136-39e47a92fa0512
995666meclizine hydrochloride 25 MG Oral TabletSCD467e464b-bbaf-4053-9136-39e47a92fa0512
995666meclizine HCl 25 MG Oral TabletPSN91b1fd1a-1da2-4aae-826f-7de0bfe621615
995666meclizine hydrochloride 25 MG Oral TabletSCD91b1fd1a-1da2-4aae-826f-7de0bfe621615
995666meclizine HCl 25 MG Oral TabletPSN4fe3c273-eb84-331c-e054-00144ff88e882
995666meclizine HCl 25 MG Oral TabletPSNb9ab298e-b7d7-44ab-a0eb-7fcbe3ea21572
995666meclizine hydrochloride 25 MG Oral TabletSCD4fe3c273-eb84-331c-e054-00144ff88e882
995666meclizine hydrochloride 25 MG Oral TabletSCDb9ab298e-b7d7-44ab-a0eb-7fcbe3ea21572
995666meclizine HCl 25 MG Oral TabletPSN46f1e0ac-d67d-4419-e054-00144ff88e881
995666meclizine HCl 25 MG Oral TabletPSN68807858-f248-5aa8-e053-2991aa0a793c1
995666meclizine HCl 25 MG Oral TabletPSNc66d4869-630e-4b9f-acfb-9fdd4d06d7de1
995666meclizine hydrochloride 25 MG Oral TabletSCD46f1e0ac-d67d-4419-e054-00144ff88e881
995666meclizine hydrochloride 25 MG Oral TabletSCD68807858-f248-5aa8-e053-2991aa0a793c1
995666meclizine hydrochloride 25 MG Oral TabletSCDc66d4869-630e-4b9f-acfb-9fdd4d06d7de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-014-0142806001401100 TABLET in 1 BOTTLE (42806-014-01) 100 tablet2012-04-300000-00-00NoNoCurrent
42806-014-10428060014101000 TABLET in 1 BOTTLE (42806-014-10) 1000 tablet2012-04-300000-00-00NoNoCurrent