Home NDC 73521-030 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213978-001 TYRVAYA VARENICLINE TARTRATE EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213978-001 10456396 2035-10-19 U-1900 Drug product 2021-11-04 N213978-001 11224598 2035-10-19 U-1900 2022-01-28 N213978-001 11903941 2035-10-19 U-1900 2024-03-08 N213978-001 11903942 2035-10-19 Drug product 2024-03-08 N213978-001 11903943 2035-10-19 U-1900 2024-03-08 N213978-001 11911380 2035-10-19 U-1900 2024-03-08 N213978-001 12576080 2035-10-19 U-1900 2026-04-10 N213978-001 12653824 2035-10-19 Drug product 2026-07-07 N213978-001 9504644 2035-10-19 U-1900 2021-11-04 N213978-001 9504645 2035-10-19 Drug product 2021-11-04 N213978-001 9532944 2035-10-19 U-1900 2021-11-04 N213978-001 9597284 2035-10-19 U-1900 2021-11-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SOLUTION / NASAL RLD, RS 2021-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SOLUTION / NASAL RLD, RS 2021-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SOLUTION / NASAL RLD, RS 2021-10-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SOLUTION / NASAL RLD, RS 2021-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SOLUTION / NASAL RLD, RS 2021-10-15 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SOLUTION / NASAL RLD, RS 2021-10-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213978-001 TYRVAYA EQ 0.03MG BASE/SPRAY SPRAY / NASAL RLD, RS 2021-10-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 259 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213978-001 10456396 2035-10-19 U-1900 Drug product 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 11224598 2035-10-19 U-1900 2022-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 11903941 2035-10-19 U-1900 2024-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 11903942 2035-10-19 Drug product 2024-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 11903943 2035-10-19 U-1900 2024-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 11911380 2035-10-19 U-1900 2024-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 9504644 2035-10-19 U-1900 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 9504645 2035-10-19 Drug product 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 9532944 2035-10-19 U-1900 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213978-001 9597284 2035-10-19 U-1900 2021-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 10456396 2035-10-19 U-1900 Drug product 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 11224598 2035-10-19 U-1900 2022-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 11903941 2035-10-19 U-1900 2024-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 11903942 2035-10-19 Drug product 2024-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 11903943 2035-10-19 U-1900 2024-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 11911380 2035-10-19 U-1900 2024-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 9504644 2035-10-19 U-1900 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 9504645 2035-10-19 Drug product 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 9532944 2035-10-19 U-1900 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213978-001 9597284 2035-10-19 U-1900 2021-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213978-001 10456396 2035-10-19 U-1900 Drug product 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 11224598 2035-10-19 U-1900 2022-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 11903941 2035-10-19 U-1900 2024-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 11903942 2035-10-19 Drug product 2024-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 11903943 2035-10-19 U-1900 2024-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 11911380 2035-10-19 U-1900 2024-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 9504644 2035-10-19 U-1900 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 9504645 2035-10-19 Drug product 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 9532944 2035-10-19 U-1900 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213978-001 9597284 2035-10-19 U-1900 2021-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 10456396 2035-10-19 U-1900 Drug product 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 11224598 2035-10-19 U-1900 2022-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 11903941 2035-10-19 U-1900 2024-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 11903942 2035-10-19 Drug product 2024-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 11903943 2035-10-19 U-1900 2024-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 11911380 2035-10-19 U-1900 2024-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 9504644 2035-10-19 U-1900 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 9504645 2035-10-19 Drug product 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 9532944 2035-10-19 U-1900 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213978-001 9597284 2035-10-19 U-1900 2021-11-04 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Tyrvaya
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARENICLINE TARTRATE .03 mg/.05mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 82269ASB48 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2572365 Internal RxNorm lookup 2572371 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73521-030-02 Tyrvaya 4.2 mL in 1 BOTTLE, PUMP SPRAY 4.2 14 73521-030-02 Tyrvaya 2 in 1 CARTON SPRAY 2 14 73521-030-90 Tyrvaya 1 in 1 CARTON SPRAY 1 14 73521-030-90 Tyrvaya 4.2 mL in 1 BOTTLE, PUMP SPRAY 4.2 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73521-030 TYRVAYA (VARENICLINE) SPRAY [OYSTER POINT PHARMA, INC.] 14 Current NDC, Legacy NDC, 4 package rows 20250311_014c93dc-5737-479c-a9f0-aaadac1ac298.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73521-030-02 73521003002 2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP 2021-10-20 0000-00-00 No No Current 73521-030-90 73521003090 1 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP 2021-10-20 0000-00-00 Yes No Current