NDC 0378-2588

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride

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

Product ID0378-2588_00b7c512-5d41-4218-870f-9838716c761e
NDC0378-2588
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine Hydrochloride
Generic NameHydroxyzine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-07-23
Marketing End Date2019-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA091176
Labeler NameMylan Pharmaceuticals Inc.
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-2588-10

1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2588-10)
Marketing Start Date2010-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2588-01 [00378258801]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091176
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-23
Marketing End Date2019-09-30

NDC 0378-2588-10 [00378258810]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091176
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-23
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:07d01d5a-7243-4389-8548-01846df24cdb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995258
  • 995281
  • 995218

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0904-6618Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4530HydrOXYzine HydrochlorideHydrOXYzine Hydrochloride
    68071-4633Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4499Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4763Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4748Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68084-253Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4622Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68084-254Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68084-255Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68151-0150Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68462-354hydroxyzine hydrochloridehydroxyzine hydrochloride
    68462-352hydroxyzine hydrochloridehydroxyzine hydrochloride
    68462-353hydroxyzine hydrochloridehydroxyzine hydrochloride
    68788-9737Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68788-9307Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68788-9776HydrOXYzine HydrochlorideHydrOXYzine Hydrochloride
    70518-0425Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-0487Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-0488Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-1730Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1832Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1265Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-1965Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1931Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1692Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-1964Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70934-150Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    71205-155Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70938-001Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0246Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0268Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    71205-083Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0935Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0986Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
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