NDC 52959-481

HYDROXYZINE HYDROCHLORIDE

Hydroxyzine Hydrochloride

HYDROXYZINE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j Harkins Company Inc.. The primary component is Hydroxyzine Hydrochloride.

Product ID52959-481_5f140045-e8ea-28c2-e053-2991aa0a46cc
NDC52959-481
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYZINE HYDROCHLORIDE
Generic NameHydroxyzine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA204279
Labeler NameH.J Harkins Company inc.
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-481-25

25 TABLET in 1 CONTAINER (52959-481-25)
Marketing Start Date2017-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-481-10 [52959048110]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-481-15 [52959048115]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-481-25 [52959048125]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-481-60 [52959048160]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-481-30 [52959048130]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-481-20 [52959048120]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-481-12 [52959048112]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-481-06 [52959048106]

HYDROXYZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:5f140045-e8e9-28c2-e053-2991aa0a46cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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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