NDC 68788-7189

LEVOCETIRIZINE DIHYDROCHLORIDE

Levocetirizine Dihydrochloride

LEVOCETIRIZINE DIHYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Levocetirizine Dihydrochloride.

Product ID68788-7189_4e05c009-00c2-4f3f-9cbf-28bba40840ad
NDC68788-7189
Product TypeHuman Prescription Drug
Proprietary NameLEVOCETIRIZINE DIHYDROCHLORIDE
Generic NameLevocetirizine Dihydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-07-17
Marketing CategoryANDA / ANDA
Application NumberANDA205564
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameLEVOCETIRIZINE DIHYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68788-7189-1

100 TABLET, FILM COATED in 1 BOTTLE (68788-7189-1)
Marketing Start Date2018-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7189-6 [68788718906]

LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-17

NDC 68788-7189-1 [68788718901]

LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-17

NDC 68788-7189-9 [68788718909]

LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-17

NDC 68788-7189-3 [68788718903]

LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-17

Drug Details

Active Ingredients

IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:e3859c68-fb3e-4728-ba56-59ded0a301a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855172
  • Pharmacological Class

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

    NDC Crossover Matching brand name "LEVOCETIRIZINE DIHYDROCHLORIDE" or generic name "Levocetirizine Dihydrochloride"

    NDCBrand NameGeneric Name
    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
    68071-4629LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE
    68462-346LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE
    68788-6892Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    68788-7189LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE
    69117-1000Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    69842-761levocetirizine dihydrochloridelevocetirizine dihydrochloride
    70518-0931Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    71205-210Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    71335-0162Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    71205-204levocetirizine dihydrochloridelevocetirizine dihydrochloride
    71335-0789Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    71335-0940levocetirizine dihydrochloridelevocetirizine dihydrochloride
    71335-0418LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE
    42291-386Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    42543-712levocetirizine dihydrochloridelevocetirizine dihydrochloride
    42571-122Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    42571-312Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    43063-831Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    43063-479Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    43598-669levocetirizine dihydrochloridelevocetirizine dihydrochloride
    43598-810levocetirizine dihydrochloridelevocetirizine dihydrochloride
    43598-735levocetirizine dihydrochloridelevocetirizine dihydrochloride
    45802-594levocetirizine dihydrochloridelevocetirizine dihydrochloride
    45802-680levocetirizine dihydrochloridelevocetirizine dihydrochloride
    50090-2061LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE
    50090-3698Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    50090-2591Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    50228-136levocetirizine dihydrochloridelevocetirizine dihydrochloride
    51672-4161Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    53217-375Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    55111-282levocetirizine dihydrochloridelevocetirizine dihydrochloride
    60505-0403LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE
    60505-3713Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    61442-460Levocetirizine DihydrochlorideLevocetirizine Dihydrochloride
    63187-663levocetirizine dihydrochloridelevocetirizine dihydrochloride

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