NDC 65162-444

Meclizine Hydrochloride

Meclizine Hydrochloride

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

Product ID65162-444_58305e9a-709c-42b2-9676-efb94deb82ad
NDC65162-444
Product TypeHuman Prescription Drug
Proprietary NameMeclizine Hydrochloride
Generic NameMeclizine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-02-12
Marketing CategoryANDA / ANDA
Application NumberANDA201451
Labeler NameAmneal Pharmaceuticals LLC
Substance NameMECLIZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAntiemetic [EPC],Emesis Suppression [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65162-444-03

30 TABLET in 1 BOTTLE (65162-444-03)
Marketing Start Date2010-02-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-444-10 [65162044410]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201451
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-12

NDC 65162-444-11 [65162044411]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201451
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-12

NDC 65162-444-50 [65162044450]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201451
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-12

NDC 65162-444-03 [65162044403]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201451
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-12

NDC 65162-444-60 [65162044460]

Meclizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA201451
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-12

Drug Details

Active Ingredients

IngredientStrength
MECLIZINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:666dc4d8-7b16-4c3c-84e4-645548dbee68
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995666
  • 995686
  • 995624
  • UPC Code
  • 0365162441031
  • 0365162444032
  • 0365162442038
  • Pharmacological Class

    • Antiemetic [EPC]
    • Emesis Suppression [PE]

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

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.