NDC 61919-646

HYDROXYZINE HCL

Hydroxyzine Hcl

HYDROXYZINE HCL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Hydroxyzine Hydrochloride.

• Product ID: 61919-646_2bd1350a-5bb6-33c1-e054-00144ff88e88
• NDC: 61919-646
• Product Type: Human Prescription Drug
• Proprietary Name: HYDROXYZINE HCL
• Generic Name: Hydroxyzine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-02-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040804
• Labeler Name: DIRECT RX
• Substance Name: HYDROXYZINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-646-30

30 TABLET, FILM COATED in 1 BOTTLE (61919-646-30)

• Marketing Start Date: 2016-02-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-646-30 [61919064630]

HYDROXYZINE HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA040804
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-02-12

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYZINE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 2bd1350a-5bb5-33c1-e054-00144ff88e88
• Manufacturer:
  • DIRECT RX
• UNII:
  • 76755771U3
• RxNorm Concept Unique ID - RxCUI:
  • 995218

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