Meclizine Hydrochloride

Product NDC
70710-1161
11-digit product format
707101161
Labeler code
70710
Product ID
70710-1161_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
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, 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
70710-1161-0Meclizine Hydrochloride1000 in 1 BOTTLETABLET10003
70710-1161-1Meclizine Hydrochloride100 in 1 BOTTLETABLET1003
70710-1161-2Meclizine Hydrochloride10 in 1 BLISTER PACKTABLET103
70710-1161-3Meclizine Hydrochloride30 in 1 BOTTLETABLET303
70710-1161-4Meclizine Hydrochloride10 in 1 CARTONTABLET103
70710-1161-9Meclizine Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1161-0EA - Each70710-1161d781d963-7a58-488e-a2a2-d44e89d2ac1812021-01-08
70710-1161-1EA - Each70710-11617871bbb2-1dab-4cf9-be3f-2f0d6cb2e85b12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1161MECLIZINE 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
995624meclizine HCl 12.5 MG Oral TabletPSN947a03c5-bca0-4d97-90b9-bcd6d65882733
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 TabletSCD947a03c5-bca0-4d97-90b9-bcd6d65882733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1161-0707101161001000 TABLET in 1 BOTTLE (70710-1161-0) 1000 tablet2020-10-290000-00-00NoNoCurrent
70710-1161-170710116101100 TABLET in 1 BOTTLE (70710-1161-1) 100 tablet2020-10-290000-00-00NoNoCurrent
70710-1161-27071011610210 in 1 BLISTER PACKHistorical
70710-1161-37071011610330 TABLET in 1 BOTTLE (70710-1161-3) 30 tablet2020-10-290000-00-00NoNoCurrent
70710-1161-47071011610410 BLISTER PACK in 1 CARTON (70710-1161-4) / 10 TABLET in 1 BLISTER PACK (70710-1161-2) 10 blister pack2020-10-290000-00-00NoNoCurrent
70710-1161-97071011610990 TABLET in 1 BOTTLE (70710-1161-9) 90 tablet2020-10-290000-00-00NoNoCurrent