NDC 54838-502

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Hydroxyzine Dihydrochloride.

• Product ID: 54838-502_a85f80ea-6954-4d24-b2eb-4002a176e4a0
• NDC: 54838-502
• Product Type: Human Prescription Drug
• Proprietary Name: Hydroxyzine Hydrochloride
• Generic Name: Hydroxyzine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201674
• Labeler Name: Lannett Company, Inc.
• Substance Name: HYDROXYZINE DIHYDROCHLORIDE
• Active Ingredient Strength: 10 mg/5mL
• Pharm Classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 54838-502-80

473 mL in 1 BOTTLE, PLASTIC (54838-502-80)

• Marketing Start Date: 2013-08-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54838-502-80 [54838050280]

Hydroxyzine Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201674
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-08-21

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYZINE HYDROCHLORIDE	10 mg/5mL

OpenFDA Data

• SPL SET ID: a4fb61ae-aad6-4bd6-83fc-8b227f175df9
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • 76755771U3
• RxNorm Concept Unique ID - RxCUI:
  • 995241
• UPC Code:
  • 0354838502800

Pharmacological Class

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

Medicade Reported Pricing

54838050280 HYDROXYZINE 10 MG/5 ML SYRUP

Pricing Unit: ML | Drug Type:

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

NDC	Brand Name	Generic Name
0093-5060	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0093-5061	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0093-5062	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0121-4822	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0378-2586	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride
0378-2587	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride
0378-2588	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride
0404-9877	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0440-1617	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0517-4201	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0517-5601	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0517-5602	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0615-8037	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
0615-8082	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
0904-6617	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
0904-6618	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68071-4530	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride
68071-4633	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68071-4499	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68071-4763	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68071-4748	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68084-253	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68071-4622	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68084-254	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68084-255	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68151-0150	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68462-354	hydroxyzine hydrochloride	hydroxyzine hydrochloride
68462-352	hydroxyzine hydrochloride	hydroxyzine hydrochloride
68462-353	hydroxyzine hydrochloride	hydroxyzine hydrochloride
68788-9737	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68788-9307	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
68788-9776	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride
70518-0425	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
70518-0487	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
70518-0488	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
70518-1730	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
70518-1832	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
70518-1265	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
70518-1965	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
70518-1931	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
70518-1692	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
70518-1964	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
70934-150	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
71205-155	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
70938-001	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
71335-0246	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
71335-0268	Hydroxyzine hydrochloride	Hydroxyzine hydrochloride
71205-083	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
71335-0935	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride
71335-0986	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride