NDC 61919-856

HYDROXYZINE HCL

Hydroxyzine Hcl

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

Product ID61919-856_87c35b14-9a88-56d1-e053-2995a90a7909
NDC61919-856
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYZINE HCL
Generic NameHydroxyzine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA040602
Labeler NameDIRECT RX
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-856-30

30 TABLET, FILM COATED in 1 BOTTLE (61919-856-30)
Marketing Start Date2019-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-856-60 [61919085660]

HYDROXYZINE HCL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040602
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30

NDC 61919-856-30 [61919085630]

HYDROXYZINE HCL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040602
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE25 mg/1

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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