NDC 71610-397

hydroxyzine pamoate

Hydroxyzine Pamoate

hydroxyzine pamoate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Hydroxyzine Pamoate.

Product ID71610-397_de50cd59-5bd9-4be9-9709-bc342dd0c9ca
NDC71610-397
Product TypeHuman Prescription Drug
Proprietary Namehydroxyzine pamoate
Generic NameHydroxyzine Pamoate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-06-03
Marketing CategoryANDA / ANDA
Application NumberANDA201507
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameHYDROXYZINE PAMOATE
Active Ingredient Strength25 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71610-397-30

30 CAPSULE in 1 BOTTLE (71610-397-30)
Marketing Start Date2020-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-397-53 [71610039753]

hydroxyzine pamoate CAPSULE
Marketing CategoryANDA
Application NumberANDA201507
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

NDC 71610-397-30 [71610039730]

hydroxyzine pamoate CAPSULE
Marketing CategoryANDA
Application NumberANDA201507
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

NDC 71610-397-70 [71610039770]

hydroxyzine pamoate CAPSULE
Marketing CategoryANDA
Application NumberANDA201507
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

NDC 71610-397-80 [71610039780]

hydroxyzine pamoate CAPSULE
Marketing CategoryANDA
Application NumberANDA201507
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-03

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

OpenFDA Data

SPL SET ID:d9026566-63d8-416f-9722-92b5bdb45ed3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995253

    • Pharmacological Class

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

    NDC Crossover Matching brand name "hydroxyzine pamoate" or generic name "Hydroxyzine Pamoate"

    NDCBrand NameGeneric Name
    0115-1670Hydroxyzine PamoateHydroxyzine Pamoate
    0115-1671Hydroxyzine PamoateHydroxyzine Pamoate
    0115-1803Hydroxyzine PamoateHydroxyzine Pamoate
    0115-1804Hydroxyzine PamoateHydroxyzine Pamoate
    0185-0613Hydroxyzine PamoateHydroxyzine Pamoate
    0185-0615hydroxyzine pamoatehydroxyzine pamoate
    0185-0674hydroxyzine pamoatehydroxyzine pamoate
    0185-0676Hydroxyzine pamoateHydroxyzine Pamoate
    0555-0302Hydroxyzine PamoateHydroxyzine Pamoate
    0555-0323Hydroxyzine PamoateHydroxyzine Pamoate
    68071-1054HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE
    68071-3158hydroxyzine pamoatehydroxyzine pamoate
    68071-1811HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE
    68071-4665Hydroxyzine PamoateHydroxyzine Pamoate
    68071-4540Hydroxyzine PamoateHydroxyzine Pamoate
    68071-4509Hydroxyzine PamoateHydroxyzine Pamoate
    68084-847Hydroxyzine PamoateHydroxyzine Pamoate
    68788-0523hydroxyzine pamoatehydroxyzine pamoate
    68788-7280Hydroxyzine PamoateHydroxyzine Pamoate
    68788-7214HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE
    68788-9386HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE
    68788-9696Hydroxyzine PamoateHydroxyzine Pamoate
    68788-9129hydroxyzine pamoatehydroxyzine pamoate
    0555-0324Hydroxyzine PamoateHydroxyzine Pamoate
    70518-0209hydroxyzine pamoatehydroxyzine pamoate
    70518-0883Hydroxyzine PamoateHydroxyzine Pamoate
    70518-1659hydroxyzine pamoatehydroxyzine pamoate
    70518-1653HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE
    70518-1150Hydroxyzine PamoateHydroxyzine Pamoate
    70518-1411Hydroxyzine PamoateHydroxyzine Pamoate
    70518-1504hydroxyzine pamoatehydroxyzine pamoate
    70518-1471hydroxyzine pamoatehydroxyzine pamoate
    71205-123Hydroxyzine PamoateHydroxyzine Pamoate
    71205-087Hydroxyzine PamoateHydroxyzine Pamoate
    71335-0224HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE
    0615-0332Hydroxyzine PamoateHydroxyzine Pamoate
    71335-0438HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE
    0615-0331hydroxyzine pamoatehydroxyzine pamoate
    71335-0998Hydroxyzine PamoateHydroxyzine Pamoate
    71610-217Hydroxyzine PamoateHydroxyzine Pamoate
    71335-1058hydroxyzine pamoatehydroxyzine pamoate
    71610-239hydroxyzine pamoatehydroxyzine pamoate
    71610-095Hydroxyzine PamoateHydroxyzine Pamoate
    0615-7860hydroxyzine pamoatehydroxyzine pamoate
    10544-556Hydroxyzine PamoateHydroxyzine Pamoate
    12634-833hydroxyzine pamoatehydroxyzine pamoate
    21695-573Hydroxyzine PamoateHydroxyzine Pamoate
    23155-675hydroxyzine pamoatehydroxyzine pamoate
    23155-674hydroxyzine pamoatehydroxyzine pamoate
    33261-858hydroxyzine pamoatehydroxyzine pamoate
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