NDC 0404-9878

Hydroxyzine

Hydroxyzine

Hydroxyzine is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Henry Schein, Inc.. The primary component is Hydroxyzine Dihydrochloride.

Product ID0404-9878_9c270144-36ab-4dc6-b377-5523fa4be75a
NDC0404-9878
Product TypeHuman Prescription Drug
Proprietary NameHydroxyzine
Generic NameHydroxyzine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2022-01-17
Marketing CategoryANDA /
Application NumberANDA087408
Labeler NameHenry Schein, Inc.
Substance NameHYDROXYZINE DIHYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesAntihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0404-9878-02

1 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-01-17
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0404-9878HydroxyzineHydroxyzine
0615-1525HydroxyzineHydroxyzine Hydrochloride
0615-1526HydroxyzineHydroxyzine Hydrochloride
0615-1527HydroxyzineHydroxyzine Hydrochloride
0904-0358HydroxyzineHydroxyzine Hydrochloride
0904-0359HydroxyzineHydroxyzine Hydrochloride
10544-209HydroxyzineHydroxyzine
10544-210HydroxyzineHydroxyzine
52584-007HydroxyzineHydroxyzine
52584-601HydroxyzineHydroxyzine
52584-610HydroxyzineHydroxyzine
68788-9466HydroxyzineHydroxyzine
10544-226Hydroxyzine HydrochlorideHydroxyzine
10544-227Hydroxyzine HydrochlorideHydroxyzine
43063-435Hydroxyzine HydrochlorideHydroxyzine
55289-912Hydroxyzine HydrochlorideHydroxyzine
60429-223Hydroxyzine HydrochlorideHydroxyzine
60429-224Hydroxyzine HydrochlorideHydroxyzine
60429-225Hydroxyzine HydrochlorideHydroxyzine
63187-492Hydroxyzine HydrochlorideHydroxyzine
63629-6716Hydroxyzine HydrochlorideHydroxyzine
65162-575Hydroxyzine HydrochlorideHydroxyzine
65162-577Hydroxyzine HydrochlorideHydroxyzine
65162-671Hydroxyzine HydrochlorideHydroxyzine
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.