FDA.reportPublic FDA data

Zerviate

Product NDC
71776-024
11-digit product format
717760024
Labeler code
71776
Product ID
71776-024_ec80e400-7e79-45ba-e053-2a95a90a18ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Eyevance Pharmaceuticals
Application
NDA208694
Marketing category
NDA
Marketing start
2019-02-19
Marketing end
0000-00-00
Substance
CETIRIZINE
Active strength
2 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71776-024-012025-01-30C16284748780-12cef2736-7890-d83d-e063-dadaa90ab31fZERVIATE™ (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE. Initial U.S. Approval: 1995
71776-024-052025-01-30C16284748780-12cef2736-7890-d83d-e063-dadaa90ab31fZERVIATE™ (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE. Initial U.S. Approval: 1995
71776-024-302025-01-30C16284748780-12cef2736-7890-d83d-e063-dadaa90ab31fZERVIATE™ (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71776-024-01Zerviate0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.211
71776-024-01Zerviate5 in 1 CARTONSOLUTION/ DROPS511
71776-024-05Zerviate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS511
71776-024-05Zerviate1 in 1 CARTONSOLUTION/ DROPS111
71776-024-30Zerviate0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.211
71776-024-30Zerviate30 in 1 CARTONSOLUTION/ DROPS3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71776-024-30EA - Each71776-024830d981c-7cf9-4966-ab5b-44b9c678bb4812020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71776-024ZERVIATE (CETIRIZINE) SOLUTION/ DROPS [EYEVANCE PHARMACEUTICALS]11Legacy NDC, 6 package rows20231010_3e6fecc1-df71-4c01-a654-f55635617a7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119476cetirizine 0.24 % Ophthalmic SolutionPSN3e6fecc1-df71-4c01-a654-f55635617a7f11
2119481ZERVIATE 0.24 % Ophthalmic SolutionPSN3e6fecc1-df71-4c01-a654-f55635617a7f11
2119481cetirizine 2.4 MG/ML Ophthalmic Solution [Zerviate]SBD3e6fecc1-df71-4c01-a654-f55635617a7f11
2119476cetirizine 2.4 MG/ML Ophthalmic SolutionSCD3e6fecc1-df71-4c01-a654-f55635617a7f11
2119476cetirizine 0.24 % Ophthalmic SolutionSY3e6fecc1-df71-4c01-a654-f55635617a7f11
2119476cetirizine 2.4 MG (as cetirizine HCl 2.85 MG) per 1 ML Ophthalmic SolutionSY3e6fecc1-df71-4c01-a654-f55635617a7f11
2119481Zerviate 0.24 % Ophthalmic SolutionSY3e6fecc1-df71-4c01-a654-f55635617a7f11
2119481Zerviate 2.4 MG/ML Ophthalmic SolutionSY3e6fecc1-df71-4c01-a654-f55635617a7f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71776-024-01717760024015 VIAL, SINGLE-USE in 1 CARTON (71776-024-01) > .2 mL in 1 VIAL, SINGLE-USE2020-03-230000-00-00NoNoCurrent
71776-024-05717760024051 BOTTLE, DROPPER in 1 CARTON (71776-024-05) > 5 mL in 1 BOTTLE, DROPPER2019-02-190000-00-00NoNoCurrent
71776-024-307177600243030 VIAL, SINGLE-USE in 1 CARTON (71776-024-30) > .2 mL in 1 VIAL, SINGLE-USE2020-03-230000-00-00NoNoCurrent