NDC 61919-301

MECLIZINE

Meclizine

MECLIZINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Meclizine Hydrochloride.

Product ID61919-301_3218d48a-aa81-0105-e054-00144ff88e88
NDC61919-301
Product TypeHuman Prescription Drug
Proprietary NameMECLIZINE
Generic NameMeclizine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-04-28
Marketing CategoryANDA / ANDA
Application NumberANDA200294
Labeler NameDIRECT RX
Substance NameMECLIZINE HYDROCHLORIDE
Active Ingredient Strength13 mg/1
Pharm ClassesAntiemetic [EPC],Emesis Suppression [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-301-30

30 TABLET in 1 BOTTLE (61919-301-30)
Marketing Start Date2016-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-301-30 [61919030130]

MECLIZINE TABLET
Marketing CategoryANDA
Application NumberANDA200294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-28

Drug Details

Active Ingredients

IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:3218d48a-aa80-0105-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995624

    • Pharmacological Class

    • Antiemetic [EPC]
    • Emesis Suppression [PE]

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

    NDCBrand NameGeneric Name
    0536-1297MECLIZINEMeclizine HCl 12.5 mg
    16103-386MECLIZINEMeclizine HCl 12.5 mg
    16103-387MECLIZINEMeclizine HCl 25mg
    50090-2601MECLIZINEMeclizine HCl 25mg
    50090-2652MECLIZINEMeclizine HCl 25mg
    50090-3017MECLIZINEMeclizine HCl 12.5 mg
    50090-5358MECLIZINEMeclizine HCl 25mg
    50090-5359MECLIZINEMeclizine HCl 25mg
    53002-7651MECLIZINEMeclizine HCl 25mg
    61919-301MECLIZINEMECLIZINE
    66424-386MECLIZINEMeclizine HCl 12.5 mg
    66424-387MECLIZINEMeclizine HCl 25mg
    67296-1750MECLIZINEMeclizine HCl 25mg
    68071-4584MECLIZINEMeclizine HCl 25mg
    68071-4986MECLIZINEMeclizine HCl 25mg
    71335-1215MECLIZINEMECLIZINE
    73057-386MECLIZINEMECLIZINE
    73057-387MECLIZINEMECLIZINE
    0378-5485Meclizine HydrochlorideMeclizine
    0378-5486Meclizine HydrochlorideMeclizine
    0615-8303Meclizine HydrochlorideMeclizine
    0904-6516Meclizine HydrochlorideMeclizine
    43063-662Meclizine HydrochlorideMeclizine
    50090-2048Meclizine HydrochlorideMeclizine
    50268-522Meclizine HydrochlorideMeclizine
    51079-423Meclizine HydrochlorideMeclizine
    51079-511Meclizine HydrochlorideMeclizine
    65162-441Meclizine HydrochlorideMeclizine
    68071-4299Meclizine HydrochlorideMeclizine
    68071-4352Meclizine HydrochlorideMeclizine
    70518-1402Meclizine HydrochlorideMeclizine
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