ArmonAir RespiClick

Product NDC: 59310-705
11-digit product format: 593100705
Labeler code: 59310
Product ID: 59310-705_a4fb1c80-6000-4779-947f-680e979ac6f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluticasone Propionate
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Teva Respiratory, LLC
Application: NDA208798
Marketing category: NDA
Marketing start: 2017-08-07
Marketing end: 2019-09-30
Substance: FLUTICASONE PROPIONATE
Active strength: 55 ug/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59310-705		D	Discontinued by firm	2026-10-21
excluded package	package	59310-705	59310-705-06	D	Discontinued by firm	2026-10-21
excluded package	package	59310-705	59310-705-08	D	Discontinued by firm	2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59310-705-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59310-705-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59310-705-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59310-705-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59310-705-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59310-705-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59310-705-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59310-705-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59310-705-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59310-705-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59310-705-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59310-705-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59310-705-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59310-705-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59310-705-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59310-705-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59310-705-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59310-705-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59310-705-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59310-705-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59310-705-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59310-705-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59310-705-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59310-705-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208798-001	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27
N208798-002	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27
N208798-003	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27
N208798-004	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20
N208798-005	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20
N208798-006	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20
N208798-007	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09
N208798-008	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08

Orange Book patents#

Current patent rows page 1 of 1 · 56 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N208798-001	10195375	2031-02-14	Drug product	2019-03-05
N208798-001	10195375*PED	2031-08-14	Pediatric extension
N208798-001	11969544	2039-08-20	Drug product	2024-05-29
N208798-001	11969544*PED	2040-02-20	Pediatric extension
N208798-002	10195375	2031-02-14	Drug product	2019-03-05
N208798-002	10195375*PED	2031-08-14	Pediatric extension
N208798-002	11969544	2039-08-20	Drug product	2024-05-29
N208798-002	11969544*PED	2040-02-20	Pediatric extension
N208798-003	10195375	2031-02-14	Drug product	2019-03-05
N208798-003	10195375*PED	2031-08-14	Pediatric extension
N208798-003	11969544	2039-08-20	Drug product	2024-05-29
N208798-003	11969544*PED	2040-02-20	Pediatric extension
N208798-004	10195375	2031-02-14	Drug product	2020-03-20
N208798-004	10195375*PED	2031-08-14	Pediatric extension
N208798-004	10918816	2035-12-14	Drug product	2021-03-18
N208798-004	10918816*PED	2036-06-14	Pediatric extension
N208798-004	11969544	2039-08-20	Drug product	2024-05-29
N208798-004	11344685	2039-09-26	Drug product	2022-06-29
N208798-004	11969544*PED	2040-02-20	Pediatric extension
N208798-004	11344685*PED	2040-03-26	Pediatric extension
N208798-004	11173259	2040-07-06	Drug product	2021-12-08
N208798-004	11173259*PED	2041-01-06	Pediatric extension
N208798-005	10195375	2031-02-14	Drug product	2020-03-20
N208798-005	10195375*PED	2031-08-14	Pediatric extension
N208798-005	10918816	2035-12-14	Drug product	2021-03-18
N208798-005	10918816*PED	2036-06-14	Pediatric extension
N208798-005	11969544	2039-08-20	Drug product	2024-05-29
N208798-005	11344685	2039-09-26	Drug product	2022-06-29
N208798-005	11969544*PED	2040-02-20	Pediatric extension
N208798-005	11344685*PED	2040-03-26	Pediatric extension
N208798-005	11173259	2040-07-06	Drug product	2021-12-08
N208798-005	11173259*PED	2041-01-06	Pediatric extension
N208798-006	10195375	2031-02-14	Drug product	2020-03-20
N208798-006	10195375*PED	2031-08-14	Pediatric extension
N208798-006	10918816	2035-12-14	Drug product	2021-03-18
N208798-006	10918816*PED	2036-06-14	Pediatric extension
N208798-006	11969544	2039-08-20	Drug product	2024-05-29
N208798-006	11344685	2039-09-26	Drug product	2022-06-29
N208798-006	11969544*PED	2040-02-20	Pediatric extension
N208798-006	11344685*PED	2040-03-26	Pediatric extension
N208798-006	11173259	2040-07-06	Drug product	2021-12-08
N208798-006	11173259*PED	2041-01-06	Pediatric extension
N208798-007	10195375	2031-02-14	Drug product	2021-08-05
N208798-007	10195375*PED	2031-08-14	Pediatric extension
N208798-007	11969544	2039-08-20	Drug product	2024-05-29
N208798-007	11969544*PED	2040-02-20	Pediatric extension
N208798-008	10195375	2031-02-14	Drug product	2022-05-05
N208798-008	10195375*PED	2031-08-14	Pediatric extension
N208798-008	10918816	2035-12-14	Drug product	2022-05-05
N208798-008	10918816*PED	2036-06-14	Pediatric extension
N208798-008	11969544	2039-08-20	Drug product	2024-05-29
N208798-008	11344685	2039-09-26	Drug product	2022-06-29
N208798-008	11969544*PED	2040-02-20	Pediatric extension
N208798-008	11344685*PED	2040-03-26	Pediatric extension
N208798-008	11173259	2040-07-06	Drug product	2022-05-05
N208798-008	11173259*PED	2041-01-06	Pediatric extension

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.

Product history page 1 of 8 · 320 observed 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	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`31067a03dcf5…`

Observed Orange Book patent history#

Patent history page 1 of 240 · 9,577 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208798-001	10195375	2031-02-14	Drug product	2019-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-001	10195375*PED	2031-08-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-001	11969544	2039-08-20	Drug product	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-001	11969544*PED	2040-02-20	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-002	10195375	2031-02-14	Drug product	2019-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-002	10195375*PED	2031-08-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-002	11969544	2039-08-20	Drug product	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-002	11969544*PED	2040-02-20	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-003	10195375	2031-02-14	Drug product	2019-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-003	10195375*PED	2031-08-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-003	11969544	2039-08-20	Drug product	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-003	11969544*PED	2040-02-20	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	10195375	2031-02-14	Drug product	2020-03-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	10195375*PED	2031-08-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	10918816	2035-12-14	Drug product	2021-03-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	10918816*PED	2036-06-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	11969544	2039-08-20	Drug product	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	11344685	2039-09-26	Drug product	2022-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	11969544*PED	2040-02-20	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	11344685*PED	2040-03-26	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	11173259	2040-07-06	Drug product	2021-12-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-004	11173259*PED	2041-01-06	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	10195375	2031-02-14	Drug product	2020-03-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	10195375*PED	2031-08-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	10918816	2035-12-14	Drug product	2021-03-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	10918816*PED	2036-06-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	11969544	2039-08-20	Drug product	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	11344685	2039-09-26	Drug product	2022-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	11969544*PED	2040-02-20	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	11344685*PED	2040-03-26	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	11173259	2040-07-06	Drug product	2021-12-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-005	11173259*PED	2041-01-06	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	10195375	2031-02-14	Drug product	2020-03-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	10195375*PED	2031-08-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	10918816	2035-12-14	Drug product	2021-03-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	10918816*PED	2036-06-14	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	11969544	2039-08-20	Drug product	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	11344685	2039-09-26	Drug product	2022-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	11969544*PED	2040-02-20	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208798-006	11344685*PED	2040-03-26	Pediatric extension		`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 4 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N208798-001	NP	2020-01-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208798-002	NP	2020-01-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208798-003	NP	2020-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208798-001	NP	2020-01-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208798-002	NP	2020-01-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208798-003	NP	2020-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208798-001	NPP	2024-07-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208798-001	PED	2025-01-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208798-004	NPP	2024-07-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208798-004	PED	2025-01-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208798-007	NS	2024-07-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208798-007	PED	2025-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208798-001	NPP	2024-07-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208798-001	PED	2025-01-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208798-004	NPP	2024-07-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208798-004	PED	2025-01-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208798-007	NS	2024-07-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208798-007	PED	2025-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208798-001	NPP	2024-07-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208798-001	PED	2025-01-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208798-004	NPP	2024-07-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208798-004	PED	2025-01-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208798-007	NS	2024-07-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208798-007	PED	2025-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208798-001	NPP	2024-07-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208798-001	PED	2025-01-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208798-004	NPP	2024-07-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208798-004	PED	2025-01-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208798-007	NS	2024-07-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208798-007	PED	2025-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208798-001	NPP	2024-07-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208798-001	PED	2025-01-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208798-004	NPP	2024-07-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208798-004	PED	2025-01-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208798-007	NS	2024-07-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208798-007	PED	2025-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208798-001	NPP	2024-07-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208798-001	PED	2025-01-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208798-004	NPP	2024-07-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208798-004	PED	2025-01-09	`a67488948f0b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59310-705-06	EA - Each	59310-705	3a0afee8-9962-4fae-bb0f-325772295f41	1	2017-09-11