NDC 10544-209

Hydroxyzine

Hydroxyzine

Hydroxyzine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Hydroxyzine Hydrochloride.

Product ID10544-209_d360cdb2-78e7-45b3-a06a-6f19e2224a58
NDC10544-209
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine
Generic NameHydroxyzine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-12-28
Marketing CategoryANDA / ANDA
Application NumberANDA088617
Labeler NameBlenheim Pharmacal, Inc.
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-209-15

15 TABLET, FILM COATED in 1 BOTTLE (10544-209-15)
Marketing Start Date2009-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-209-15 [10544020915]

Hydroxyzine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088617
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-28
Inactivation Date2019-10-29

NDC 10544-209-30 [10544020930]

Hydroxyzine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088617
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-28
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:a49c7e1a-ed02-439a-9b02-bef7d86ed464
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995218

    • Pharmacological Class

    • Antihistamine [EPC]
    • Histamine Receptor Antagonists [MoA]

    NDC Crossover Matching brand name "Hydroxyzine" or generic name "Hydroxyzine"

    NDCBrand NameGeneric Name
    0404-9878HydroxyzineHydroxyzine
    0615-1525HydroxyzineHydroxyzine Hydrochloride
    0615-1526HydroxyzineHydroxyzine Hydrochloride
    0615-1527HydroxyzineHydroxyzine Hydrochloride
    0904-0358HydroxyzineHydroxyzine Hydrochloride
    0904-0359HydroxyzineHydroxyzine Hydrochloride
    10544-209HydroxyzineHydroxyzine
    10544-210HydroxyzineHydroxyzine
    52584-007HydroxyzineHydroxyzine
    52584-601HydroxyzineHydroxyzine
    52584-610HydroxyzineHydroxyzine
    68788-9466HydroxyzineHydroxyzine
    10544-226Hydroxyzine HydrochlorideHydroxyzine
    10544-227Hydroxyzine HydrochlorideHydroxyzine
    43063-435Hydroxyzine HydrochlorideHydroxyzine
    55289-912Hydroxyzine HydrochlorideHydroxyzine
    60429-223Hydroxyzine HydrochlorideHydroxyzine
    60429-224Hydroxyzine HydrochlorideHydroxyzine
    60429-225Hydroxyzine HydrochlorideHydroxyzine
    63187-492Hydroxyzine HydrochlorideHydroxyzine
    63629-6716Hydroxyzine HydrochlorideHydroxyzine
    65162-575Hydroxyzine HydrochlorideHydroxyzine
    65162-577Hydroxyzine HydrochlorideHydroxyzine
    65162-671Hydroxyzine HydrochlorideHydroxyzine
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