FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
21695-383
11-digit product format
216950383
Labeler code
21695
Product ID
21695-383_a7839c4b-6e6e-444f-997e-2dbe28a80eaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA087127
Marketing category
ANDA
Marketing start
1981-06-03
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-383-302019-09-24C16284748780-1934fe258-486c-48b1-e053-8cdaa90a720aMeclizine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-383-30Meclizine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-383-30EA - Each21695-38372cf7e1e-7318-4e94-b6a8-49433dac8ca112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-383MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20101119_a7839c4b-6e6e-444f-997e-2dbe28a80eaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNa7839c4b-6e6e-444f-997e-2dbe28a80eaa1
995666meclizine HCl 25 MG Oral TabletPSNa7839c4b-6e6e-444f-997e-2dbe28a80eaa1
995624meclizine hydrochloride 12.5 MG Oral TabletSCDa7839c4b-6e6e-444f-997e-2dbe28a80eaa1
995666meclizine hydrochloride 25 MG Oral TabletSCDa7839c4b-6e6e-444f-997e-2dbe28a80eaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-383-302169503833030 in 1 BOTTLEHistorical