FDA.reportPublic FDA data

Tyrvaya

Product NDC
73521-030
11-digit product format
735210030
Labeler code
73521
Product ID
73521-030_b8c6f558-9cbd-4389-a8d7-a8c698c49093
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline
Dosage form
SPRAY
Route
NASAL
Labeler
Oyster Point Pharma, Inc.
Application
NDA213978
Marketing category
NDA
Marketing start
2021-10-20
Substance
VARENICLINE TARTRATE
Active strength
.03 mg/.05mL
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE.03 mg/.05mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui2572365, 2572371

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73521-030-022023-08-24C16284748780-10191ceaa-70c1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TYRVAYA safely and effectively. See full prescribing information for TYRVAYA. TYRVAYA ® (varenicline solution) nasal spray Initial U.S. Approval: 2006
73521-030-902023-08-24C16284748780-10191ceaa-70c1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TYRVAYA safely and effectively. See full prescribing information for TYRVAYA. TYRVAYA ® (varenicline solution) nasal spray Initial U.S. Approval: 2006
73521-030-022023-07-28C16284748780-10191ceaa-70c1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TYRVAYA safely and effectively. See full prescribing information for TYRVAYA. TYRVAYA ® (varenicline solution) nasal spray Initial U.S. Approval: 2006
73521-030-902023-07-28C16284748780-10191ceaa-70c1-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TYRVAYA safely and effectively. See full prescribing information for TYRVAYA. TYRVAYA ® (varenicline solution) nasal spray Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73521-030-02Tyrvaya4.2 mL in 1 BOTTLE, PUMPSPRAY4.214
73521-030-02Tyrvaya2 in 1 CARTONSPRAY214
73521-030-90Tyrvaya1 in 1 CARTONSPRAY114
73521-030-90Tyrvaya4.2 mL in 1 BOTTLE, PUMPSPRAY4.214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73521-030-02ML - Milliliter73521-030f70f7ab2-a979-4e7a-8e40-ecd423b32ee212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73521-030TYRVAYA (VARENICLINE) SPRAY [OYSTER POINT PHARMA, INC.]14Current NDC, Legacy NDC, 4 package rows20250311_014c93dc-5737-479c-a9f0-aaadac1ac298.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572371tyrvaya 0.03 MG/ACTUAT Nasal SprayPSN014c93dc-5737-479c-a9f0-aaadac1ac29814
2572365varenicline 0.03 MG/ACTUAT Nasal SprayPSN014c93dc-5737-479c-a9f0-aaadac1ac29814
2572371varenicline 0.03 MG/ACTUAT Nasal Spray [Tyrvaya]SBD014c93dc-5737-479c-a9f0-aaadac1ac29814
2572365varenicline 0.03 MG/ACTUAT Nasal SpraySCD014c93dc-5737-479c-a9f0-aaadac1ac29814
2572371Tyrvaya 0.03 MG per 0.05 ML Nasal SpraySY014c93dc-5737-479c-a9f0-aaadac1ac29814
2572371Tyrvaya 0.03 MG/ACTUAT Nasal SpraySY014c93dc-5737-479c-a9f0-aaadac1ac29814
2572365varenicline 0.03 MG per 0.05 mL (as varenicline tartrate 0.05 MG per 0.05 mL) Nasal SpraySY014c93dc-5737-479c-a9f0-aaadac1ac29814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73521-030-02735210030022 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP2021-10-200000-00-00NoNoCurrent
73521-030-90735210030901 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP2021-10-200000-00-00YesNoCurrent