Fluticasone Propionate and Salmeterol

Product NDC: 63629-8809
Requested package NDC: 63629-8809-1
11-digit product format: 636298809
Labeler code: 63629
Product ID: 63629-8809_3853b8ad-898f-4783-87b2-8b5952dcaf5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluticasone Propionate and Salmeterol
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Bryant Ranch Prepack
Application: NDA208799
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-04-28
Substance: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength: 113; 14 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 255 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208799-001	AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208799-002	AIRDUO RESPICLICK	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208799-003	AIRDUO RESPICLICK	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208799-004	AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208799-005	AIRDUO DIGIHALER	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208799-006	AIRDUO DIGIHALER	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER / INHALATION	RLD	2019-07-12	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 211 · 8,426 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208799-001	10195375	2031-02-14		Drug product	2019-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-001	10195375*PED	2031-08-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-001	9066957	2034-10-06	U-645	Drug product	2017-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-001	9415008	2034-10-06	U-645	Drug product	2017-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-001	9066957*PED	2035-04-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-001	9415008*PED	2035-04-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-001	11969544	2039-08-20		Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-001	11969544*PED	2040-02-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-002	10195375	2031-02-14		Drug product	2019-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-002	10195375*PED	2031-08-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-002	9066957	2034-10-06	U-645	Drug product	2017-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-002	9066957*PED	2035-04-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-002	11969544	2039-08-20		Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-002	11969544*PED	2040-02-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-003	10195375	2031-02-14		Drug product	2019-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-003	10195375*PED	2031-08-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-003	9066957	2034-10-06	U-645	Drug product	2017-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-003	9066957*PED	2035-04-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-003	11969544	2039-08-20		Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-003	11969544*PED	2040-02-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	10195375	2031-02-14		Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	10195375*PED	2031-08-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	9066957	2034-10-06	U-645	Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	9415008	2034-10-06	U-645	Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	9066957*PED	2035-04-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	9415008*PED	2035-04-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	10918816	2035-12-14		Drug product	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	10918816*PED	2036-06-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	11969544	2039-08-20		Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	11344685	2039-09-26		Drug product	2022-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	11969544*PED	2040-02-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	11344685*PED	2040-03-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	11173259	2040-07-06		Drug product	2021-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-004	11173259*PED	2041-01-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-005	10195375	2031-02-14		Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-005	10195375*PED	2031-08-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-005	9066957	2034-10-06	U-645	Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-005	9066957*PED	2035-04-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-005	10918816	2035-12-14		Drug product	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208799-005	10918816*PED	2036-06-14		Pediatric extension		`84e616aacf4f…`

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…`

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: Fluticasone Propionate and Salmeterol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	113 ug/1
SALMETEROL XINAFOATE	14 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O2GMZ0LF5W	Internal UNII lookup
6EW8Q962A5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1918194	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
84654ac7-e2b4-4fa1-b127-69aee03aecc0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
3bcd721e-0555-4bc3-96c6-690471ff9d94	Product name	1	20171113
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
f3c5232f-03de-44f5-996a-90cd9c08bc60	Product name	1	20170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2	Product name	1	20140508
667f427a-8698-a508-767a-53ed61b4c2e9	Product name	1	20140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9	Product name	1	20140508
6df84e13-2223-fa46-1e26-17e2f58a1e1c	Product name	1	20140508
811691fa-281f-6d95-fb49-e2337fb2e146	Product name	1	20140508
90fec588-984c-4375-cfd4-7e40114bdf80	Product name	1	20140508
9c1d3c48-b162-204b-f55b-e0f25c31c52e	Product name	1	20140508
9fdb6139-394b-1510-4baf-bde68c419789	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8809-1	Fluticasone Propionate and Salmeterol	1 in 1 POUCH	POWDER, METERED	1		103
63629-8809-1	Fluticasone Propionate and Salmeterol	1 in 1 CARTON	POWDER, METERED	1		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8809-1	EA - Each	63629-8809	098c77b1-bde7-4358-9873-db2d92a5fcc9	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8809	FLUTICASONE PROPIONATE AND SALMETEROL POWDER, METERED [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 2 package rows	20240504_84654ac7-e2b4-4fa1-b127-69aee03aecc0.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 · 4 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 ndc (package): 63629-8809-1 ndc (product): 63629-8809 ndc11 (package): 63629880901

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1918194	fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations	PSN	84654ac7-e2b4-4fa1-b127-69aee03aecc0	103
1918194	60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler	SCD	84654ac7-e2b4-4fa1-b127-69aee03aecc0	103
1918194	fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS	SY	84654ac7-e2b4-4fa1-b127-69aee03aecc0	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8809-1	63629880901	1 POUCH in 1 CARTON (63629-8809-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	1 pouch	2017-04-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluticasone Propionate and Salmeterol - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	103