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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
HDP7W44CIOMECLIZINE HYDROCHLORIDE31884-77-2MECLIZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1539-0707711539001000 TABLET in 1 BOTTLE (70771-1539-0) 1000 tablet2020-10-29NoNoHistorical
70771-1539-170771153901100 TABLET in 1 BOTTLE (70771-1539-1) 100 tablet2020-10-29NoNoHistorical
70771-1539-37077115390330 TABLET in 1 BOTTLE (70771-1539-3) 30 tablet2020-10-29NoNoHistorical
70771-1539-47077115390410 BLISTER PACK in 1 CARTON (70771-1539-4) / 10 TABLET in 1 BLISTER PACK (70771-1539-2) 10 blister pack2020-10-29NoNoHistorical
70771-1539-97077115390990 TABLET in 1 BOTTLE (70771-1539-9) 90 tablet2020-10-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meclizine HydrochlorideZydus Lifesciences Limited2023-08-28HUMAN PRESCRIPTION DRUG LABEL2