NDC 54879-006

Hydroxyzine HCl

Hydroxyzine Hcl

Hydroxyzine HCl is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Sti Pharma Llc. The primary component is Hydroxyzine Hydrochloride.

• Product ID: 54879-006_2cd16e7a-22d9-4119-b146-51778a36a4ea
• NDC: 54879-006
• Product Type: Human Prescription Drug
• Proprietary Name: Hydroxyzine HCl
• Generic Name: Hydroxyzine Hcl
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1982-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA086880
• Labeler Name: STI Pharma LLC
• Substance Name: HYDROXYZINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/5mL
• Pharm Classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 54879-006-16

473 mL in 1 BOTTLE (54879-006-16)

• Marketing Start Date: 1982-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54879-006-16 [54879000616]

Hydroxyzine HCl SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA086880
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1982-01-01

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYZINE HYDROCHLORIDE	10 mg/5mL

OpenFDA Data

• SPL SET ID: fe0c3083-2a8f-4f5f-af9f-b1f668e77417
• Manufacturer:
  • STI Pharma LLC
• UNII:
  • 76755771U3
• RxNorm Concept Unique ID - RxCUI:
  • 995241

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
54879-006	Hydroxyzine HCl	Hydroxyzine HCl
61919-217	HYDROXYZINE HCL	HYDROXYZINE HCL
61919-646	HYDROXYZINE HCL	HYDROXYZINE HCL
61919-856	HYDROXYZINE HCL	HYDROXYZINE HCL
80425-0173	Hydroxyzine HCL	Hydroxyzine HCL