ZERVIATE

Product NDC
82667-015
11-digit product format
826670015
Labeler code
82667
Product ID
82667-015_33794d74-d742-82b5-e063-6294a90a6f32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cetirizine
Dosage form
FOR SOLUTION
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA208694
Marketing category
NDA
Marketing start
2025-04-30
Substance
CETIRIZINE
Active strength
2.4 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZERVIATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE2.4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYO7261ME24
Rxcui2119476, 2119481

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-015-24ZERVIATE1 in 1 CARTONFOR SOLUTION12
82667-015-24ZERVIATE30 in 1 POUCHFOR SOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-015-24EA - Each82667-015bf953b0c-1aa0-4c35-9df1-e8a58ed4572b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-015ZERVIATE (CETIRIZINE) FOR SOLUTION [HARROW EYE, LLC]2Current NDC, 2 package rows20250430_6fc5ef4e-4aea-4c34-8d51-0c07ab9aad59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119476cetirizine 0.24 % Ophthalmic SolutionPSN6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592
2119481ZERVIATE 0.24 % Ophthalmic SolutionPSN6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592
2119481cetirizine 2.4 MG/ML Ophthalmic Solution [Zerviate]SBD6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592
2119476cetirizine 2.4 MG/ML Ophthalmic SolutionSCD6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592
2119476cetirizine 0.24 % Ophthalmic SolutionSY6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592
2119476cetirizine 2.4 MG (as cetirizine HCl 2.85 MG) per 1 ML Ophthalmic SolutionSY6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592
2119481Zerviate 0.24 % Ophthalmic SolutionSY6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592
2119481Zerviate 2.4 MG/ML Ophthalmic SolutionSY6fc5ef4e-4aea-4c34-8d51-0c07ab9aad592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82667-015-24826670015241 POUCH in 1 CARTON (82667-015-24) / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE1 pouch2025-04-30NoNoHistorical