NDC 0121-4822

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Hydroxyzine Hydrochloride.

Product ID0121-4822_f86276e9-0aff-4be7-895d-437a11fd12ac
NDC0121-4822
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine Hydrochloride
Generic NameHydroxyzine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA087294
Labeler NamePharmaceutical Associates, Inc.
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0121-4822-12

4 TRAY in 1 CASE (0121-4822-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 12.5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4822-12 [00121482212]

Hydroxyzine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA087294
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-01
Inactivation Date2020-01-31

NDC 0121-4822-25 [00121482225]

Hydroxyzine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA087294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE10 mg/5mL

OpenFDA Data

SPL SET ID:85e3c789-a740-4a09-a810-9808c3d0f7d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995241

    • 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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