NDC 63629-1856

Hydroxyzine hydrochloride

Hydroxyzine Hydrochloride

Hydroxyzine hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Hydroxyzine Hydrochloride.

Product ID63629-1856_6d9b56b6-ae7c-4b5c-a6dd-19c8e17c5801
NDC63629-1856
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine hydrochloride
Generic NameHydroxyzine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA204279
Labeler NameBryant Ranch Prepack
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63629-1856-1

30 TABLET, FILM COATED in 1 BOTTLE (63629-1856-1)
Marketing Start Date2015-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-1856-7 [63629185607]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

NDC 63629-1856-3 [63629185603]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

NDC 63629-1856-4 [63629185604]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

NDC 63629-1856-2 [63629185602]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

NDC 63629-1856-5 [63629185605]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

NDC 63629-1856-1 [63629185601]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

NDC 63629-1856-8 [63629185608]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

NDC 63629-1856-6 [63629185606]

Hydroxyzine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-30
Marketing End Date2018-08-30

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:9714d429-e7f6-4adf-b3f0-cb21e6edb433
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995258
  • 995281
  • 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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