NDC 71776-024

Zerviate

Cetirizine

Zerviate is a Ophthalmic Solution, Gel Forming / Drops in the Human Prescription Drug category. It is labeled and distributed by Eyevance Pharmaceuticals. The primary component is Cetirizine.

• Product ID: 71776-024_83d7bbf1-de71-7d6e-e053-2991aa0a1de9
• NDC: 71776-024
• Product Type: Human Prescription Drug
• Proprietary Name: Zerviate
• Generic Name: Cetirizine
• Dosage Form: Solution, Gel Forming / Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2019-02-19
• Marketing Category: NDA / NDA
• Application Number: NDA208694
• Labeler Name: Eyevance Pharmaceuticals
• Substance Name: CETIRIZINE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71776-024-01

5 VIAL, SINGLE-USE in 1 CARTON (71776-024-01) > .2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2020-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71776-024-01 [71776002401]

Zerviate SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208694
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-07

NDC 71776-024-30 [71776002430]

Zerviate SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208694
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-02-10

NDC 71776-024-05 [71776002405]

Zerviate SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208694
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-19

Drug Details

Active Ingredients

Ingredient	Strength
CETIRIZINE	2.4 mg/mL

OpenFDA Data

• SPL SET ID: 3e6fecc1-df71-4c01-a654-f55635617a7f
• Manufacturer:
  • Eyevance Pharmaceuticals
• UNII:
  • YO7261ME24
• RxNorm Concept Unique ID - RxCUI:
  • 2119476
  • 2119481
• UPC Code:
  • 0371776024058

Pharmacological Class

• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "Zerviate" or generic name "Cetirizine"

NDC	Brand Name	Generic Name
71776-024	Zerviate	Cetirizine
51824-076	CAREALL Cetirizine HCl	Cetirizine
0363-1040	Cetirizine	Cetirizine
11673-219	Cetirizine	Cetirizine
21695-878	Cetirizine	Cetirizine
60505-4322	Cetirizine	Cetirizine
60505-4668	Cetirizine	Cetirizine
60505-4706	Cetirizine	Cetirizine
67046-680	Cetirizine	Cetirizine
37012-939	Cetirizine Hydrochloride	Cetirizine
65162-003	Cetirizine Hydrochloride	Cetirizine
65162-005	Cetirizine Hydrochloride	Cetirizine
65162-045	Cetirizine Hydrochloride	Cetirizine
65162-046	Cetirizine Hydrochloride	Cetirizine
65162-145	Cetirizine Hydrochloride	Cetirizine
65162-146	Cetirizine Hydrochloride	Cetirizine
65162-684	Cetirizine Hydrochloride	Cetirizine
37205-820	LEADER ALL DAY ALLERGY	cetirizine