NDC 0378-5485

Meclizine Hydrochloride

Meclizine

Meclizine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Meclizine Hydrochloride.

Product ID0378-5485_bf8f38e7-8b67-4646-9a20-5cb24b2bb736
NDC0378-5485
Product TypeHuman Prescription Drug
Proprietary NameMeclizine Hydrochloride
Generic NameMeclizine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-19
Marketing End Date2020-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA202640
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMECLIZINE HYDROCHLORIDE
Active Ingredient Strength13 mg/1
Pharm ClassesAntiemetic [EPC],Emesis Suppression [PE]
NDC Exclude FlagN

Packaging

NDC 0378-5485-77

90 TABLET in 1 BOTTLE, PLASTIC (0378-5485-77)
Marketing Start Date2012-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5485-77 [00378548577]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202640
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-19
Marketing End Date2020-01-31

NDC 0378-5485-10 [00378548510]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202640
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-19
Marketing End Date2020-01-31

NDC 0378-5485-01 [00378548501]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202640
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-19
Marketing End Date2014-04-03

Drug Details

Active Ingredients

IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:595ba2cb-b31f-4cff-b86e-40e72109a582
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995666
  • 995624

    • Pharmacological Class

    • Antiemetic [EPC]
    • Emesis Suppression [PE]

    NDC Crossover Matching brand name "Meclizine Hydrochloride" or generic name "Meclizine"

    NDCBrand NameGeneric Name
    0378-5485Meclizine HydrochlorideMeclizine
    0378-5486Meclizine HydrochlorideMeclizine
    0440-1736Meclizine Hydrochloridemeclizine hydrochloride
    0536-1299Meclizine HydrochlorideMeclizine Hydrochloride
    0615-1553Meclizine Hydrochloridemeclizine hydrochloride
    0615-1554Meclizine Hydrochloridemeclizine hydrochloride
    0615-8052Meclizine HydrochlorideMeclizine Hydrochloride
    0615-8224Meclizine HydrochlorideMeclizine Hydrochloride
    0615-8303Meclizine HydrochlorideMeclizine
    0904-6516Meclizine HydrochlorideMeclizine
    0904-6517Meclizine HydrochlorideMeclizine Hydrochloride
    10544-081MECLIZINE HYDROCHLORIDEMeclizine Hydrocloride
    10544-108Meclizine Hydrochloridemeclizine hydrochloride
    12634-424Meclizine HydrochlorideMeclizine Hydrochloride
    16571-660Meclizine HydrochlorideMeclizine Hydrochloride
    16571-661Meclizine HydrochlorideMeclizine Hydrochloride
    16571-662Meclizine HydrochlorideMeclizine Hydrochloride
    16571-663Meclizine HydrochlorideMeclizine Hydrochloride
    21695-237Meclizine HydrochlorideMeclizine Hydrochloride
    21695-383Meclizine HydrochlorideMeclizine Hydrochloride
    24689-138Meclizine HydrochlorideMeclizine Hydrochloride
    24689-139Meclizine HydrochlorideMeclizine Hydrochloride
    24689-146Meclizine HydrochlorideMeclizine Hydrochloride
    33261-718MECLIZINE HYDROCHLORIDEMeclizine Hydrocloride
    35356-901MECLIZINE HYDROCHLORIDEMeclizine Hydrochloride
    68071-3017MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    68071-3308MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    68071-4299Meclizine HydrochlorideMeclizine Hydrochloride
    68071-4488MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    68071-4352Meclizine HydrochlorideMeclizine Hydrochloride
    68071-4694MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    68071-4372Meclizine HydrochlorideMeclizine Hydrochloride
    68071-4497Meclizine HydrochlorideMeclizine Hydrochloride
    68084-490Meclizine HydrochlorideMeclizine Hydrochloride
    68084-491Meclizine HydrochlorideMeclizine Hydrochloride
    69677-153Meclizine HydrochlorideMeclizine Hydrochloride
    70518-0447MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    70518-0421Meclizine HydrochlorideMeclizine Hydrochloride
    70518-0422Meclizine HydrochlorideMeclizine Hydrochloride
    70518-1308MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    70518-1402Meclizine HydrochlorideMeclizine Hydrochloride
    70934-138Meclizine HydrochlorideMeclizine Hydrochloride
    71335-0732Meclizine HydrochlorideMeclizine Hydrochloride
    71335-0814Meclizine HydrochlorideMeclizine Hydrochloride
    71335-0153MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    71335-0189Meclizine HydrochlorideMeclizine Hydrochloride
    71335-0503MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    75921-121MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    35356-914MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
    42291-609Meclizine HydrochlorideMeclizine Hydrochloride
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