NDC 68788-9466

Hydroxyzine

Hydroxyzine Hydrochloride

Hydroxyzine is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Hydroxyzine Hydrochloride.

Product ID68788-9466_52798ad3-fc55-401b-a122-f7ba01f875a8
NDC68788-9466
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine
Generic NameHydroxyzine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-08-21
Marketing CategoryANDA / ANDA
Application NumberANDA201674
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68788-9466-4

473 mL in 1 BOTTLE, PLASTIC (68788-9466-4)
Marketing Start Date2015-08-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9466-4 [68788946604]

Hydroxyzine SOLUTION
Marketing CategoryANDA
Application NumberANDA201674
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-21

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE10 mg/5mL

OpenFDA Data

SPL SET ID:84691197-2289-4f2b-b1fb-086b7d91a299
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995241

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0404-9878HydroxyzineHydroxyzine
    0615-1525HydroxyzineHydroxyzine Hydrochloride
    0615-1526HydroxyzineHydroxyzine Hydrochloride
    0615-1527HydroxyzineHydroxyzine Hydrochloride
    0904-0358HydroxyzineHydroxyzine Hydrochloride
    0904-0359HydroxyzineHydroxyzine Hydrochloride
    68788-9466HydroxyzineHydroxyzine
    10544-209HydroxyzineHydroxyzine
    10544-210HydroxyzineHydroxyzine
    52584-007HydroxyzineHydroxyzine
    52584-601HydroxyzineHydroxyzine
    52584-610HydroxyzineHydroxyzine
    0093-5060Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0093-5061Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0093-5062Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0121-4822Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0378-2586Hydroxyzine Hydrochloridehydroxyzine hydrochloride
    0378-2587Hydroxyzine Hydrochloridehydroxyzine hydrochloride
    0378-2588Hydroxyzine Hydrochloridehydroxyzine hydrochloride
    0404-9877Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0440-1617Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0517-4201Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0517-5601Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0517-5602Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    0615-8037Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    0615-8082Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    0904-6617Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
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