NDC 0904-0358

Hydroxyzine

Hydroxyzine Hydrochloride

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

Product ID0904-0358_8c97b943-1051-4d87-84f5-8b0cc0602ffd
NDC0904-0358
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine
Generic NameHydroxyzine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA040787
Labeler NameMajor Pharmaceuticals
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 0904-0358-40

500 TABLET, FILM COATED in 1 BOTTLE (0904-0358-40)
Marketing Start Date2007-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-0358-40 [00904035840]

Hydroxyzine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040787
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-20

NDC 0904-0358-80 [00904035880]

Hydroxyzine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040787
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-20

NDC 0904-0358-60 [00904035860]

Hydroxyzine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040787
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-20
Marketing End Date2014-06-30

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:34bd2df3-5f54-4818-8172-085885de3d1a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995258
  • 995281
  • 995218
    • UPC Code
  • 0309040357601
  • 0309040359605
  • 0309040358608

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0404-9878HydroxyzineHydroxyzine
    0615-1525HydroxyzineHydroxyzine Hydrochloride
    0615-1526HydroxyzineHydroxyzine Hydrochloride
    0615-1527HydroxyzineHydroxyzine Hydrochloride
    0904-0358HydroxyzineHydroxyzine Hydrochloride
    0904-0359HydroxyzineHydroxyzine Hydrochloride
    68788-9466HydroxyzineHydroxyzine
    10544-209HydroxyzineHydroxyzine
    10544-210HydroxyzineHydroxyzine
    52584-007HydroxyzineHydroxyzine
    52584-601HydroxyzineHydroxyzine
    52584-610HydroxyzineHydroxyzine
    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
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