Meclizine Hydrochloride

Product NDC
70771-1539
11-digit product format
707711539
Labeler code
70771
Product ID
70771-1539_83635604-72b7-4eb4-b8d9-5ae556041b4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
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
70771-1539-0Meclizine Hydrochloride1000 in 1 BOTTLETABLET10002
70771-1539-1Meclizine Hydrochloride100 in 1 BOTTLETABLET1002
70771-1539-2Meclizine Hydrochloride10 in 1 BLISTER PACKTABLET102
70771-1539-3Meclizine Hydrochloride30 in 1 BOTTLETABLET302
70771-1539-4Meclizine Hydrochloride10 in 1 CARTONTABLET102
70771-1539-9Meclizine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1539MECLIZINE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 6 package rows20230829_cf157a71-f80a-4fb7-b892-7102b65a8ec0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNcf157a71-f80a-4fb7-b892-7102b65a8ec02
995666meclizine HCl 25 MG Oral TabletPSNcf157a71-f80a-4fb7-b892-7102b65a8ec02
995624meclizine hydrochloride 12.5 MG Oral TabletSCDcf157a71-f80a-4fb7-b892-7102b65a8ec02
995666meclizine hydrochloride 25 MG Oral TabletSCDcf157a71-f80a-4fb7-b892-7102b65a8ec02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1539-0707711539001000 TABLET in 1 BOTTLE (70771-1539-0) 1000 tablet2020-10-290000-00-00NoNoCurrent
70771-1539-170771153901100 TABLET in 1 BOTTLE (70771-1539-1) 100 tablet2020-10-290000-00-00NoNoCurrent
70771-1539-27077115390210 in 1 BLISTER PACKHistorical
70771-1539-37077115390330 TABLET in 1 BOTTLE (70771-1539-3) 30 tablet2020-10-290000-00-00NoNoCurrent
70771-1539-47077115390410 BLISTER PACK in 1 CARTON (70771-1539-4) / 10 TABLET in 1 BLISTER PACK (70771-1539-2) 10 blister pack2020-10-290000-00-00NoNoCurrent
70771-1539-97077115390990 TABLET in 1 BOTTLE (70771-1539-9) 90 tablet2020-10-290000-00-00NoNoCurrent