NDC 42571-312

Levocetirizine Dihydrochloride

Levocetirizine Dihydrochloride

Levocetirizine Dihydrochloride is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Levocetirizine Dihydrochloride.

Product ID42571-312_8e02a912-a369-1e37-e053-2a95a90a14f8
NDC42571-312
Product TypeHuman Otc Drug
Proprietary NameLevocetirizine Dihydrochloride
Generic NameLevocetirizine Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA211551
Labeler NameMicro Labs Limited
Substance NameLEVOCETIRIZINE DIHYDROCHLORIDE
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42571-312-11

100 BLISTER PACK in 1 CARTON (42571-312-11) > 10 TABLET in 1 BLISTER PACK (42571-312-32)
Marketing Start Date2019-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42571-312-11 [42571031211]

Levocetirizine Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA211551
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-01

NDC 42571-312-18 [42571031218]

Levocetirizine Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA211551
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-01

NDC 42571-312-32 [42571031232]

Levocetirizine Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA211551
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-22

NDC 42571-312-53 [42571031253]

Levocetirizine Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA211551
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-01

NDC 42571-312-90 [42571031290]

Levocetirizine Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA211551
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-01

Drug Details

Active Ingredients

IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:78ff8e86-ee5b-4626-aa81-49e974febf1d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855172
    • UPC Code
  • 0342571312909

    • 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
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