NDC 52584-007

Hydroxyzine

Hydroxyzine

Hydroxyzine is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Hydroxyzine Hydrochloride.

Product ID52584-007_30fc2820-b126-4809-ba63-ba4996d7975d
NDC52584-007
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine
Generic NameHydroxyzine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2010-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA087408
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-007-25

1 VIAL, SINGLE-DOSE in 1 BAG (52584-007-25) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2010-03-01
Marketing End Date2023-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-007-25 [52584000725]

Hydroxyzine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA087408
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-01

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:9c6ec419-5d3b-4053-9970-42a30458b92a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1794552

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0404-9878HydroxyzineHydroxyzine
    0615-1525HydroxyzineHydroxyzine Hydrochloride
    0615-1526HydroxyzineHydroxyzine Hydrochloride
    0615-1527HydroxyzineHydroxyzine Hydrochloride
    0904-0358HydroxyzineHydroxyzine Hydrochloride
    0904-0359HydroxyzineHydroxyzine Hydrochloride
    10544-209HydroxyzineHydroxyzine
    10544-210HydroxyzineHydroxyzine
    52584-007HydroxyzineHydroxyzine
    52584-601HydroxyzineHydroxyzine
    52584-610HydroxyzineHydroxyzine
    68788-9466HydroxyzineHydroxyzine
    10544-226Hydroxyzine HydrochlorideHydroxyzine
    10544-227Hydroxyzine HydrochlorideHydroxyzine
    43063-435Hydroxyzine HydrochlorideHydroxyzine
    55289-912Hydroxyzine HydrochlorideHydroxyzine
    60429-223Hydroxyzine HydrochlorideHydroxyzine
    60429-224Hydroxyzine HydrochlorideHydroxyzine
    60429-225Hydroxyzine HydrochlorideHydroxyzine
    63187-492Hydroxyzine HydrochlorideHydroxyzine
    63629-6716Hydroxyzine HydrochlorideHydroxyzine
    65162-575Hydroxyzine HydrochlorideHydroxyzine
    65162-577Hydroxyzine HydrochlorideHydroxyzine
    65162-671Hydroxyzine HydrochlorideHydroxyzine
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