NDC 71335-0935

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride

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

Product ID71335-0935_069271f0-3100-4271-81a1-384ed4ba1fd4
NDC71335-0935
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine Hydrochloride
Generic NameHydroxyzine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA088618
Labeler NameBryant Ranch Prepack
Substance NameHYDROXYZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0935-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-0935-1)
Marketing Start Date2018-08-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0935-4 [71335093504]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-28

NDC 71335-0935-6 [71335093506]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-28

NDC 71335-0935-2 [71335093502]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-28

NDC 71335-0935-1 [71335093501]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-28

NDC 71335-0935-7 [71335093507]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-28

NDC 71335-0935-5 [71335093505]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-28

NDC 71335-0935-8 [71335093508]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-28

NDC 71335-0935-3 [71335093503]

Hydroxyzine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA088618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-28

Drug Details

Active Ingredients

IngredientStrength
HYDROXYZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:93d117dd-e2bf-4daa-abe3-d4fefed3313c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995258
  • 995281
  • 995218
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0904-6618Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4530HydrOXYzine HydrochlorideHydrOXYzine Hydrochloride
    68071-4633Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4499Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4763Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4748Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68084-253Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68071-4622Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68084-254Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68084-255Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68151-0150Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68462-354hydroxyzine hydrochloridehydroxyzine hydrochloride
    68462-352hydroxyzine hydrochloridehydroxyzine hydrochloride
    68462-353hydroxyzine hydrochloridehydroxyzine hydrochloride
    68788-9737Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68788-9307Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    68788-9776HydrOXYzine HydrochlorideHydrOXYzine Hydrochloride
    70518-0425Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-0487Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-0488Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-1730Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1832Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1265Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-1965Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1931Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70518-1692Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    70518-1964Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70934-150Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    71205-155Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    70938-001Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0246Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0268Hydroxyzine hydrochlorideHydroxyzine hydrochloride
    71205-083Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0935Hydroxyzine HydrochlorideHydroxyzine Hydrochloride
    71335-0986Hydroxyzine HydrochlorideHydroxyzine Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.