NDC 0024-5804

Xyzal

Levocetirizine Dihydrochloride

Xyzal is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Levocetirizine Dihydrochloride.

Product ID0024-5804_194514af-c484-4843-86dd-a0a6b32a7047
NDC0024-5804
Product TypeHuman Prescription Drug
Proprietary NameXyzal
Generic NameLevocetirizine Dihydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-07-24
Marketing CategoryNDA / NDA
Application NumberNDA022157
Labeler NameSanofi-Aventis U.S. LLC
Substance NameLEVOCETIRIZINE DIHYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0024-5804-05

1 BOTTLE in 1 CARTON (0024-5804-05) > 148 mL in 1 BOTTLE
Marketing Start Date2017-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0024-5804-05 [00024580405]

Xyzal SOLUTION
Marketing CategoryNDA
Application NumberNDA022157
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24

Drug Details

Active Ingredients

IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:a6ca9f62-c065-4eda-bf95-97165cdd5fec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855170
  • 855172
  • 855174
  • 855168

    • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Xyzal" or generic name "Levocetirizine Dihydrochloride"

    NDCBrand NameGeneric Name
    0024-5803Xyzallevocetirizine dihydrochloride
    0024-5804Xyzallevocetirizine dihydrochloride
    0363-3901allergy relieflevocetirizine dihydrochloride
    11822-0241allergy relieflevocetirizine dihydrochloride
    21130-732Allergy Relieflevocetirizine dihydrochloride
    0113-0241good sense levocetirizinelevocetirizine dihydrochloride
    0363-2241levocetirizinelevocetirizine dihydrochloride
    0093-7701Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    0363-5528levocetirizine dihydrochloridelevocetirizine dihydrochloride
    0363-5529levocetirizine dihydrochloridelevocetirizine dihydrochloride
    0527-1917Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    0536-1144levocetirizine dihydrochloridelevocetirizine dihydrochloride
    10135-639Levocetirizine Dihydrochloridelevocetirizine Dihydrochloride
    11673-847levocetirizine dihydrochloridelevocetirizine dihydrochloride
    11822-5252levocetirizine dihydrochloridelevocetirizine dihydrochloride
    30142-717levocetirizine dihydrochloridelevocetirizine dihydrochloride
    31722-551Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    31722-659levocetirizine dihydrochloridelevocetirizine dihydrochloride
    33261-947Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    33342-200LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE
    37808-126levocetirizine dihydrochloridelevocetirizine dihydrochloride
    41163-938levocetirizine dihydrochloridelevocetirizine dihydrochloride
    36800-241Topcare All Day Allergylevocetirizine dihydrochloride
    41167-3510Xyzal Allergy 24HRLevocetirizine dihydrochloride

    Trademark Results [Xyzal]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XYZAL
    XYZAL
    75874693 2479307 Live/Registered
    UCB BIOPHARMA SPRL
    1999-12-17
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