NDC 52584-610

Hydroxyzine

Hydroxyzine

Hydroxyzine is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Hydroxyzine Hydrochloride.

• Product ID: 52584-610_753b6e22-f596-454f-bd57-ee560b95f9d6
• NDC: 52584-610
• Product Type: Human Prescription Drug
• Proprietary Name: Hydroxyzine
• Generic Name: Hydroxyzine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2010-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA087408
• Labeler Name: General Injectables & Vaccines, Inc
• Substance Name: HYDROXYZINE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52584-610-25

1 VIAL, MULTI-DOSE in 1 BAG (52584-610-25) > 10 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2010-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-610-25 [52584061025]

Hydroxyzine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA087408
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-03-01

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYZINE HYDROCHLORIDE	50 mg/mL

OpenFDA Data

• SPL SET ID: d834dad1-aedc-48d8-941d-3de56ce04069
• Manufacturer:
  • General Injectables & Vaccines, Inc
• UNII:
  • 76755771U3
• RxNorm Concept Unique ID - RxCUI:
  • 995285

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0404-9878	Hydroxyzine	Hydroxyzine
0615-1525	Hydroxyzine	Hydroxyzine Hydrochloride
0615-1526	Hydroxyzine	Hydroxyzine Hydrochloride
0615-1527	Hydroxyzine	Hydroxyzine Hydrochloride
0904-0358	Hydroxyzine	Hydroxyzine Hydrochloride
0904-0359	Hydroxyzine	Hydroxyzine Hydrochloride
10544-209	Hydroxyzine	Hydroxyzine
10544-210	Hydroxyzine	Hydroxyzine
52584-007	Hydroxyzine	Hydroxyzine
52584-601	Hydroxyzine	Hydroxyzine
52584-610	Hydroxyzine	Hydroxyzine
68788-9466	Hydroxyzine	Hydroxyzine
10544-226	Hydroxyzine Hydrochloride	Hydroxyzine
10544-227	Hydroxyzine Hydrochloride	Hydroxyzine
43063-435	Hydroxyzine Hydrochloride	Hydroxyzine
55289-912	Hydroxyzine Hydrochloride	Hydroxyzine
60429-223	Hydroxyzine Hydrochloride	Hydroxyzine
60429-224	Hydroxyzine Hydrochloride	Hydroxyzine
60429-225	Hydroxyzine Hydrochloride	Hydroxyzine
63187-492	Hydroxyzine Hydrochloride	Hydroxyzine
63629-6716	Hydroxyzine Hydrochloride	Hydroxyzine
65162-575	Hydroxyzine Hydrochloride	Hydroxyzine
65162-577	Hydroxyzine Hydrochloride	Hydroxyzine
65162-671	Hydroxyzine Hydrochloride	Hydroxyzine