Tyrvaya

Product NDC: 73521-030
11-digit product format: 735210030
Labeler code: 73521
Product ID: 73521-030_5e895ca8-2639-a6d5-e063-6294a90a90c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: varenicline
Dosage form: SPRAY
Route: NASAL
Labeler: Harrow Eye, LLC
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`caaa826d4ba7…`
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 8 · 295 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11224598	2035-10-19	U-1900		2022-01-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11903941	2035-10-19	U-1900		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11903942	2035-10-19		Drug product	2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11903943	2035-10-19	U-1900		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11911380	2035-10-19	U-1900		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	12576080	2035-10-19	U-1900		2026-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	12653824	2035-10-19		Drug product	2026-07-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9504644	2035-10-19	U-1900		2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9504645	2035-10-19		Drug product	2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9532944	2035-10-19	U-1900		2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9597284	2035-10-19	U-1900		2021-11-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11224598	2035-10-19	U-1900		2022-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11903941	2035-10-19	U-1900		2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11903942	2035-10-19		Drug product	2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11903943	2035-10-19	U-1900		2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11911380	2035-10-19	U-1900		2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	12576080	2035-10-19	U-1900		2026-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	12653824	2035-10-19		Drug product	2026-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9504644	2035-10-19	U-1900		2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9504645	2035-10-19		Drug product	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9532944	2035-10-19	U-1900		2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9597284	2035-10-19	U-1900		2021-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11224598	2035-10-19	U-1900		2022-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11903941	2035-10-19	U-1900		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11903942	2035-10-19		Drug product	2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11903943	2035-10-19	U-1900		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11911380	2035-10-19	U-1900		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	12576080	2035-10-19	U-1900		2026-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	12653824	2035-10-19		Drug product	2026-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9504644	2035-10-19	U-1900		2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9504645	2035-10-19		Drug product	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9532944	2035-10-19	U-1900		2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9597284	2035-10-19	U-1900		2021-11-04	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213978-001	NP	2024-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213978-001	NP	2024-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213978-001	NP	2024-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213978-001	NP	2024-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213978-001	NP	2024-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213978-001	NP	2024-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213978-001	NP	2024-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213978-001	NP	2024-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213978-001	NP	2024-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213978-001	NP	2024-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213978-001	NP	2024-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213978-001	NP	2024-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213978-001	NP	2024-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213978-001	NP	2024-10-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213978-001	NP	2024-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213978-001	NP	2024-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213978-001	NP	2024-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213978-001	NP	2024-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213978-001	NP	2024-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213978-001	NP	2024-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213978-001	NP	2024-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213978-001	NP	2024-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213978-001	NP	2024-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213978-001	NP	2024-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213978-001	NP	2024-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213978-001	NP	2024-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213978-001	NP	2024-10-15	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tyrvaya
Listing expiration: 2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f0bb1b01-df09-3a97-b952-a960743e615c	Product name	8	20260223
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
317a11f5-b985-4a71-b48a-5c9c00753d1c	Product name	1	20220511
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
73521-030-02	2023-08-24	These 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
73521-030-02	2023-08-24	These 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
73521-030-02	2023-08-24	These 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
73521-030-02	2023-08-24	These 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
73521-030-90	2023-08-24	These 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
73521-030-90	2023-08-24	These 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
73521-030-90	2023-08-24	These 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
73521-030-90	2023-08-24	These 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
73521-030-02	2023-07-28	These 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
73521-030-02	2023-07-28	These 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
73521-030-02	2023-07-28	These 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
73521-030-02	2023-07-28	These 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
73521-030-90	2023-07-28	These 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
73521-030-90	2023-07-28	These 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
73521-030-90	2023-07-28	These 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
73521-030-90	2023-07-28	These 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 NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73521-030-02	ML - Milliliter	73521-030	f70f7ab2-a979-4e7a-8e40-ecd423b32ee2	1	2021-11-09

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82269ASB48	VARENICLINE TARTRATE	375815-87-5	VARENICLINE TARTRATE
W6HS99O8ZO	VARENICLINE	249296-44-4	varenicline

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2572371	tyrvaya 0.03 MG/ACTUAT Nasal Spray	PSN	014c93dc-5737-479c-a9f0-aaadac1ac298	14
2572365	varenicline 0.03 MG/ACTUAT Nasal Spray	PSN	014c93dc-5737-479c-a9f0-aaadac1ac298	14
2572371	varenicline 0.03 MG/ACTUAT Nasal Spray [Tyrvaya]	SBD	014c93dc-5737-479c-a9f0-aaadac1ac298	14
2572365	varenicline 0.03 MG/ACTUAT Nasal Spray	SCD	014c93dc-5737-479c-a9f0-aaadac1ac298	14
2572371	Tyrvaya 0.03 MG per 0.05 ML Nasal Spray	SY	014c93dc-5737-479c-a9f0-aaadac1ac298	14
2572371	Tyrvaya 0.03 MG/ACTUAT Nasal Spray	SY	014c93dc-5737-479c-a9f0-aaadac1ac298	14
2572365	varenicline 0.03 MG per 0.05 mL (as varenicline tartrate 0.05 MG per 0.05 mL) Nasal Spray	SY	014c93dc-5737-479c-a9f0-aaadac1ac298	14

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