NDC 0615-1526

Hydroxyzine

Hydroxyzine Hydrochloride

Hydroxyzine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Hydroxyzine Hydrochloride.

Product ID0615-1526_b6d71446-c2be-4930-8dcf-bb6690512c2a
NDC0615-1526
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine
Generic NameHydroxyzine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA040786
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-1526-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-1526-39)
Marketing Start Date2007-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-1526-39 [00615152639]

Hydroxyzine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:367f5dab-95c0-4025-b578-c40e79a7c4f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995258
  • 995281
  • 995218

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.