NDC 57664-114

HydrOXYzine hydrochloride

Hydroxyzine Hydrochloride

HydrOXYzine hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Caraco Pharmaceutical Laboratories, Ltd.. The primary component is Hydroxyzine Hydrochloride.

Product ID57664-114_f5bf497c-a72c-44b0-902b-44d11bbbad1c
NDC57664-114
Product TypeHuman Prescription Drug
Proprietary NameHydrOXYzine hydrochloride
Generic NameHydroxyzine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA040899
Labeler NameCaraco Pharmaceutical Laboratories, Ltd.
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57664-114-88

100 TABLET in 1 BOTTLE (57664-114-88)
Marketing Start Date2009-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-114-13 [57664011413]

HydrOXYzine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-31
Inactivation Date2019-10-21

NDC 57664-114-83 [57664011483]

HydrOXYzine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-31
Inactivation Date2019-10-21

NDC 57664-114-88 [57664011488]

HydrOXYzine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-31
Inactivation Date2019-10-21

NDC 57664-114-08 [57664011408]

HydrOXYzine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-31
Inactivation Date2019-10-21

NDC 57664-114-18 [57664011418]

HydrOXYzine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-31
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:81f9d88f-c50b-4c6a-a25b-46fa162a503e
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.