HYDROXYZINE HYDROCHLORIDE Film-coated tablet Ref.[116212] Active ingredients: Hydroxyzine

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

Hydroxyzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.

Molecular Formula: C₂₁H₂₇ClN₂O₂ · 2HCl
Molecular Weight: 447.83

Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water.

Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide.

How Supplied
Hydroxyzine Hydrochloride Tablets, USP are available as follows: 10 mg tablets: round, film coated white tablets. Debossed H on one side and 500 on the reverse side. They are available as follows: Bottles of 100: NDC 62135-573-01 Bottles of 120: NDC 62135-573-12 Bottles of 500: NDC 62135-573-05 25 mg tablets: round, film coated white tablets. Debossed H over 501 on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 62135-574-01 Bottles of 120: NDC 62135-574-12 Bottles of 500: NDC 62135-574-05 50 mg tablets: round, film coated white tablets. Debossed H over 502 on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 62135-575-01 Bottles of 120: NDC 62135-575-12 Bottles of 500: NDC 62135-575-05 Manufactured for: Chartwell RX, LLC., Congers, NY 10920

How Supplied

Hydroxyzine Hydrochloride Tablets, USP are available as follows:

10 mg tablets: round, film coated white tablets. Debossed H on one side and 500 on the reverse side. They are available as follows:

Bottles of 100: NDC 62135-573-01

Bottles of 120: NDC 62135-573-12

Bottles of 500: NDC 62135-573-05

25 mg tablets: round, film coated white tablets. Debossed H over 501 on one side and plain on the reverse side. They are available as follows:

Bottles of 100: NDC 62135-574-01

Bottles of 120: NDC 62135-574-12

Bottles of 500: NDC 62135-574-05

50 mg tablets: round, film coated white tablets. Debossed H over 502 on one side and plain on the reverse side. They are available as follows:

Bottles of 100: NDC 62135-575-01

Bottles of 120: NDC 62135-575-12

Bottles of 500: NDC 62135-575-05

Manufactured for: Chartwell RX, LLC., Congers, NY 10920

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