FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
21695-237
11-digit product format
216950237
Labeler code
21695
Product ID
21695-237_a7839c4b-6e6e-444f-997e-2dbe28a80eaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA087128
Marketing category
ANDA
Marketing start
1981-06-03
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 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
21695-237-102019-09-24C16284748780-1934fe258-486c-48b1-e053-8cdaa90a720aMeclizine Hydrochloride
21695-237-152019-09-24C16284748780-1934fe258-486c-48b1-e053-8cdaa90a720aMeclizine Hydrochloride
21695-237-302019-09-24C16284748780-1934fe258-486c-48b1-e053-8cdaa90a720aMeclizine Hydrochloride
21695-237-402019-09-24C16284748780-1934fe258-486c-48b1-e053-8cdaa90a720aMeclizine Hydrochloride
21695-237-902019-09-24C16284748780-1934fe258-486c-48b1-e053-8cdaa90a720aMeclizine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-237-10Meclizine Hydrochloride10 in 1 BOTTLETABLET101
21695-237-15Meclizine Hydrochloride15 in 1 BOTTLETABLET151
21695-237-30Meclizine Hydrochloride30 in 1 BOTTLETABLET301
21695-237-40Meclizine Hydrochloride40 in 1 BOTTLETABLET401
21695-237-90Meclizine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-237-10EA - Each21695-2371b097281-3f43-4872-b732-89422e72609a12012-07-24
21695-237-15EA - Each21695-237369c3dd6-9b18-4618-a370-dff1508fbab012012-07-24
21695-237-30EA - Each21695-23785ade6ce-9cd3-443a-af5c-71a3e7d99b4f12012-07-24
21695-237-40EA - Each21695-237554703f9-d4cc-4f03-9180-764eabd244d212012-07-24
21695-237-90EA - Each21695-23753306a53-21b8-40ad-b9de-583b8acc4a4212012-07-24

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
21695-237MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 5 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
21695-237-102169502371010 in 1 BOTTLEHistorical
21695-237-152169502371515 in 1 BOTTLEHistorical
21695-237-302169502373030 in 1 BOTTLEHistorical
21695-237-402169502374040 in 1 BOTTLEHistorical
21695-237-902169502379090 in 1 BOTTLEHistorical