NDC 61919-217

HYDROXYZINE HCL

Hydroxyzine Hcl

HYDROXYZINE HCL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Hydroxyzine Hydrochloride.

Product ID61919-217_5bd46f87-5e1b-2d23-e053-2a91aa0a8959
NDC61919-217
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYZINE HCL
Generic NameHydroxyzine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-10-18
Marketing CategoryANDA / ANDA
Application NumberANDA204279
Labeler NameDIRECT RX
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-217-15

15 TABLET in 1 BOTTLE (61919-217-15)
Marketing Start Date2017-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-217-15 [61919021715]

HYDROXYZINE HCL TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-30

NDC 61919-217-90 [61919021790]

HYDROXYZINE HCL TABLET
Marketing CategoryANDA
Application NumberANDA204279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:5cc3aaa6-e18f-a116-e053-2991aa0a1422
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995258

    • Pharmacological Class

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

    NDC Crossover Matching brand name "HYDROXYZINE HCL" or generic name "Hydroxyzine Hcl"

    NDCBrand NameGeneric Name
    54879-006Hydroxyzine HClHydroxyzine HCl
    61919-217HYDROXYZINE HCLHYDROXYZINE HCL
    61919-646HYDROXYZINE HCLHYDROXYZINE HCL
    61919-856HYDROXYZINE HCLHYDROXYZINE HCL
    80425-0173Hydroxyzine HCLHydroxyzine HCL
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