0904-0359 : Hydroxyzine Hydrochloride 50 mg Oral Tablet


NDC: 0904-0359
Labeler: Major Pharmaceuticals
Product Type: Human Prescription Drug
Drug Name:  Hydroxyzine
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA040788
Rev. Date: 


Appearance:


Markings: K12
Shapes:  Round
Colors:  White
Size (mm): 9
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

K12: (0904-0359) Hydroxyzine Hydrochloride 50 mg Oral Tablet by Major Pharmaceuticals
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0904-0359-60: 100 TABLET, FILM COATED IN 1 BOTTLE (0904‑0359‑60)

Active Ingredients:

  • Hydroxyzine Hydrochloride

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Carnauba Wax
  • Silicon Dioxide
  • Crospovidone
  • Lactose Monohydrate
  • Polyethylene Glycol 3350
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyvinyl Alcohol
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0904-0357 Hydroxyzine Hydrochloride 10 mg Oral Tablet by Major Pharmaceuticals
  • 0904-0358 Hydroxyzine Hydrochloride 25 mg (Hydroxyzine Pamoate 42.6 mg) Oral Tablet by Major Pharmaceuticals
  • 0404-9878 Hydroxyzine 50 mg/ml Intramuscular Injection, Solution by Henry Schein, Inc.
  • 0615-1525 Hydroxyzine Hydrochloride 10 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-1526 Hydroxyzine Hydrochloride 25 mg (Hydroxyzine Pamoate 42.6 mg) Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-1527 Hydroxyzine Hydrochloride 50 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 10544-209 Hydroxyzine Hydrochloride 10 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-210 Hydroxyzine Hydrochloride 25 mg (Hydroxyzine Pamoate 42.6 mg) Oral Tablet by Blenheim Pharmacal, Inc.
  • 52584-007 Hydroxyzine 50 mg/ml Intramuscular Injection, Solution by General Injectables & Vaccines, Inc
  • 52584-201 Hydroxyzine 25 mg/ml Intramuscular Injection, Solution by General Injectables & Vaccines, Inc
  • 52584-601 Hydroxyzine 50 mg/ml Intramuscular Injection, Solution by General Injectables & Vaccines, Inc
  • 52584-610 Hydroxyzine 50 mg/ml Intramuscular Injection, Solution by General Injectables & Vaccines, Inc
  • 54838-502 Hydroxyzine 10 mg/5ml Oral Solution by Silarx Pharmaceuticals, Inc
  • 68788-9466 Hydroxyzine 10 mg/5ml Oral Solution by Preferred Pharmaceuticals, Inc.

NDC QR Code

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NDC 0904-0359 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.