Meclizine Hydrochloride

Product NDC
70710-1162
11-digit product format
707101162
Labeler code
70710
Product ID
70710-1162_f084de6d-5e11-4c6e-8643-d0a4a48fc4da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA213957
Marketing category
ANDA
Marketing start
2020-10-29
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
70710-1162-0Meclizine Hydrochloride1000 in 1 BOTTLETABLET10003
70710-1162-1Meclizine Hydrochloride100 in 1 BOTTLETABLET1003
70710-1162-2Meclizine Hydrochloride10 in 1 BLISTER PACKTABLET103
70710-1162-3Meclizine Hydrochloride30 in 1 BOTTLETABLET303
70710-1162-4Meclizine Hydrochloride10 in 1 CARTONTABLET103
70710-1162-9Meclizine Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1162-0EA - Each70710-1162084bd0b1-fcb9-4d92-a42e-b55592f8f0ee12021-01-08
70710-1162-1EA - Each70710-11627e2a4706-b90f-4b60-a2b7-7e3dd8a0bb6a12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1162MECLIZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, Legacy NDC, 6 package rows20240323_947a03c5-bca0-4d97-90b9-bcd6d6588273.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNeae4bc73-fee1-4831-b31c-8ca56fb83ad77
995666meclizine hydrochloride 25 MG Oral TabletSCDeae4bc73-fee1-4831-b31c-8ca56fb83ad77
995624meclizine HCl 12.5 MG Oral TabletPSN947a03c5-bca0-4d97-90b9-bcd6d65882733
995666meclizine HCl 25 MG Oral TabletPSN37457bd5-2fdd-b829-e063-6294a90a04f03
995666meclizine HCl 25 MG Oral TabletPSN947a03c5-bca0-4d97-90b9-bcd6d65882733
995624meclizine hydrochloride 12.5 MG Oral TabletSCD947a03c5-bca0-4d97-90b9-bcd6d65882733
995666meclizine hydrochloride 25 MG Oral TabletSCD37457bd5-2fdd-b829-e063-6294a90a04f03
995666meclizine hydrochloride 25 MG Oral TabletSCD947a03c5-bca0-4d97-90b9-bcd6d65882733
995666meclizine HCl 25 MG Oral TabletPSN2990e296-2d60-70c0-e063-6394a90abbe42
995666meclizine hydrochloride 25 MG Oral TabletSCD2990e296-2d60-70c0-e063-6394a90abbe42
995666meclizine HCl 25 MG Oral TabletPSN2e0ed1fc-53e6-a3b1-e063-6394a90af4191
995666meclizine HCl 25 MG Oral TabletPSN51c96c7a-0a38-41a5-a6c9-7f45db65fdda1
995666meclizine hydrochloride 25 MG Oral TabletSCD2e0ed1fc-53e6-a3b1-e063-6394a90af4191
995666meclizine hydrochloride 25 MG Oral TabletSCD51c96c7a-0a38-41a5-a6c9-7f45db65fdda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1162-0707101162001000 TABLET in 1 BOTTLE (70710-1162-0) 1000 tablet2020-10-290000-00-00NoNoCurrent
70710-1162-170710116201100 TABLET in 1 BOTTLE (70710-1162-1) 100 tablet2020-10-290000-00-00NoNoCurrent
70710-1162-27071011620210 in 1 BLISTER PACKHistorical
70710-1162-37071011620330 TABLET in 1 BOTTLE (70710-1162-3) 30 tablet2020-10-290000-00-00NoNoCurrent
70710-1162-47071011620410 BLISTER PACK in 1 CARTON (70710-1162-4) / 10 TABLET in 1 BLISTER PACK (70710-1162-2) 10 blister pack2020-10-290000-00-00NoNoCurrent
70710-1162-97071011620990 TABLET in 1 BOTTLE (70710-1162-9) 90 tablet2020-10-290000-00-00NoNoCurrent