AirDuo Digihaler

Product NDC: 59310-520
11-digit product format: 593100520
Labeler code: 59310
Product ID: 59310-520_d4ba573d-49f5-444d-8b91-11764ea3de8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluticasone Propionate and Salmeterol
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Teva Respiratory, LLC
Application: NDA208799
Marketing category: NDA
Marketing start: 2020-09-15
Marketing end: 0000-00-00
Substance: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength: 113 ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59310-520		D	Discontinued by firm		2026-08-03
excluded package	package	59310-520	59310-520-08	D	Discontinued by firm		2026-08-03

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 · 4 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	59310-520-08	`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	59310-520-08	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208799-001	AIRDUO RESPICLICK	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27
N208799-002	AIRDUO RESPICLICK	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27
N208799-003	AIRDUO RESPICLICK	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27
N208799-004	AIRDUO DIGIHALER	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12
N208799-005	AIRDUO DIGIHALER	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12
N208799-006	AIRDUO DIGIHALER	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12

Orange Book patents#

Current patent rows page 1 of 1 · 58 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208799-001	10195375	2031-02-14		Drug product	2019-03-05
N208799-001	10195375*PED	2031-08-14		Pediatric extension
N208799-001	9066957	2034-10-06	U-645	Drug product	2017-01-30
N208799-001	9415008	2034-10-06	U-645	Drug product	2017-01-30
N208799-001	9066957*PED	2035-04-06		Pediatric extension
N208799-001	9415008*PED	2035-04-06		Pediatric extension
N208799-001	11969544	2039-08-20		Drug product	2024-05-29
N208799-001	11969544*PED	2040-02-20		Pediatric extension
N208799-002	10195375	2031-02-14		Drug product	2019-03-05
N208799-002	10195375*PED	2031-08-14		Pediatric extension
N208799-002	9066957	2034-10-06	U-645	Drug product	2017-01-30
N208799-002	9066957*PED	2035-04-06		Pediatric extension
N208799-002	11969544	2039-08-20		Drug product	2024-05-29
N208799-002	11969544*PED	2040-02-20		Pediatric extension
N208799-003	10195375	2031-02-14		Drug product	2019-03-05
N208799-003	10195375*PED	2031-08-14		Pediatric extension
N208799-003	9066957	2034-10-06	U-645	Drug product	2017-01-30
N208799-003	9066957*PED	2035-04-06		Pediatric extension
N208799-003	11969544	2039-08-20		Drug product	2024-05-29
N208799-003	11969544*PED	2040-02-20		Pediatric extension
N208799-004	10195375	2031-02-14		Drug product	2019-08-02
N208799-004	10195375*PED	2031-08-14		Pediatric extension
N208799-004	9066957	2034-10-06	U-645	Drug product	2019-08-02
N208799-004	9415008	2034-10-06	U-645	Drug product	2019-08-02
N208799-004	9066957*PED	2035-04-06		Pediatric extension
N208799-004	9415008*PED	2035-04-06		Pediatric extension
N208799-004	10918816	2035-12-14		Drug product	2021-03-18
N208799-004	10918816*PED	2036-06-14		Pediatric extension
N208799-004	11969544	2039-08-20		Drug product	2024-05-29
N208799-004	11344685	2039-09-26		Drug product	2022-06-29
N208799-004	11969544*PED	2040-02-20		Pediatric extension
N208799-004	11344685*PED	2040-03-26		Pediatric extension
N208799-004	11173259	2040-07-06		Drug product	2021-12-08
N208799-004	11173259*PED	2041-01-06		Pediatric extension
N208799-005	10195375	2031-02-14		Drug product	2019-08-02
N208799-005	10195375*PED	2031-08-14		Pediatric extension
N208799-005	9066957	2034-10-06	U-645	Drug product	2019-08-02
N208799-005	9066957*PED	2035-04-06		Pediatric extension
N208799-005	10918816	2035-12-14		Drug product	2021-03-18
N208799-005	10918816*PED	2036-06-14		Pediatric extension
N208799-005	11969544	2039-08-20		Drug product	2024-05-29
N208799-005	11344685	2039-09-26		Drug product	2022-06-29
N208799-005	11969544*PED	2040-02-20		Pediatric extension
N208799-005	11344685*PED	2040-03-26		Pediatric extension
N208799-005	11173259	2040-07-06		Drug product	2021-12-08
N208799-005	11173259*PED	2041-01-06		Pediatric extension
N208799-006	10195375	2031-02-14		Drug product	2019-08-02
N208799-006	10195375*PED	2031-08-14		Pediatric extension
N208799-006	9066957	2034-10-06	U-645	Drug product	2019-08-02
N208799-006	9066957*PED	2035-04-06		Pediatric extension
N208799-006	10918816	2035-12-14		Drug product	2021-03-18
N208799-006	10918816*PED	2036-06-14		Pediatric extension
N208799-006	11969544	2039-08-20		Drug product	2024-05-29
N208799-006	11344685	2039-09-26		Drug product	2022-06-29
N208799-006	11969544*PED	2040-02-20		Pediatric extension
N208799-006	11344685*PED	2040-03-26		Pediatric extension
N208799-006	11173259	2040-07-06		Drug product	2021-12-08
N208799-006	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 7 · 243 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2017-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 208 · 8,310 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	N208799-001	10195375	2031-02-14		Drug product	2019-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-001	10195375*PED	2031-08-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-001	9066957	2034-10-06	U-645	Drug product	2017-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-001	9415008	2034-10-06	U-645	Drug product	2017-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-001	9066957*PED	2035-04-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-001	9415008*PED	2035-04-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-001	11969544	2039-08-20		Drug product	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-001	11969544*PED	2040-02-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-002	10195375	2031-02-14		Drug product	2019-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-002	10195375*PED	2031-08-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-002	9066957	2034-10-06	U-645	Drug product	2017-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-002	9066957*PED	2035-04-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-002	11969544	2039-08-20		Drug product	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-002	11969544*PED	2040-02-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-003	10195375	2031-02-14		Drug product	2019-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-003	10195375*PED	2031-08-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-003	9066957	2034-10-06	U-645	Drug product	2017-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-003	9066957*PED	2035-04-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-003	11969544	2039-08-20		Drug product	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-003	11969544*PED	2040-02-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	10195375	2031-02-14		Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	10195375*PED	2031-08-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	9066957	2034-10-06	U-645	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	9415008	2034-10-06	U-645	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	9066957*PED	2035-04-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	9415008*PED	2035-04-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	10918816	2035-12-14		Drug product	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	10918816*PED	2036-06-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	11969544	2039-08-20		Drug product	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	11344685	2039-09-26		Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	11969544*PED	2040-02-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	11344685*PED	2040-03-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	11173259	2040-07-06		Drug product	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-004	11173259*PED	2041-01-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-005	10195375	2031-02-14		Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-005	10195375*PED	2031-08-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-005	9066957	2034-10-06	U-645	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-005	9066957*PED	2035-04-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-005	10918816	2035-12-14		Drug product	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208799-005	10918816*PED	2036-06-14		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-001	M-61	2024-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-001	PED	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-004	M-61	2024-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208799-004	PED	2025-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208799-001	M-61	2024-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-001	PED	2025-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-004	M-61	2024-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208799-004	PED	2025-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-001	M-61	2024-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-001	PED	2025-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-004	M-61	2024-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208799-004	PED	2025-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-001	M-61	2024-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-001	PED	2025-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-004	M-61	2024-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208799-004	PED	2025-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-001	M-61	2024-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-001	PED	2025-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-004	M-61	2024-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208799-004	PED	2025-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-001	M-61	2024-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-001	PED	2025-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-004	M-61	2024-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208799-004	PED	2025-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208799-001	M-61	2024-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208799-001	PED	2025-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208799-004	M-61	2024-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208799-004	PED	2025-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208799-001	M-61	2024-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208799-001	PED	2025-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208799-004	M-61	2024-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208799-004	PED	2025-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208799-001	M-61	2024-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208799-001	PED	2025-01-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208799-004	M-61	2024-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208799-004	PED	2025-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208799-001	M-61	2024-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208799-001	PED	2025-01-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208799-004	M-61	2024-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208799-004	PED	2025-01-09	`79d66fd596c7…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59310-520	AIRDUO DIGIHALER (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER, METERED [TEVA RESPIRATORY, LLC]	13	Legacy NDC	20240430_ac79cc13-4241-427c-a69b-6b00dafcef00.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate and Salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Bryant Ranch Prepack	f3bce31d-93f9-4ca6-835e-b16e2d31b6c5	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208799 application number: NDA208799
Fluticasone Propionate and Salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Bryant Ranch Prepack	038db4da-1448-4603-a34d-2efd9059811b	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208799 application number: NDA208799
Fluticasone Propionate and Salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	A-S Medication Solutions	77269609-fb89-47c7-97cc-22e0183e91ae	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208799 application number: NDA208799
Fluticasone Propionate and Salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Bryant Ranch Prepack	84654ac7-e2b4-4fa1-b127-69aee03aecc0	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208799 application number: NDA208799
Fluticasone Propionate and Salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Teva Pharmaceuticals USA, Inc.	43a27267-2f2b-410d-9c30-9cb95f35d9a1	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208799 application number: NDA208799
AirDuo RespiClick	FLUTICASONE PROPIONATE AND SALMETEROL	Teva Respiratory, LLC	9c122b91-a11f-49ca-80bb-3eec5112db87	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208799 application number: NDA208799

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE
6EW8Q962A5	SALMETEROL XINAFOATE	94749-08-3	SALMETEROL XINAFOATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59310-520-08	59310052008	1 POUCH in 1 CARTON (59310-520-08) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER	1 pouch	2020-09-15	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AirDuo Digihaler - Teva Respiratory, LLC	Teva Respiratory, LLC	2024-04-29	HUMAN PRESCRIPTION DRUG LABEL	13