FLOVENT

Product NDC: 53002-1310
11-digit product format: 530021310
Labeler code: 53002
Product ID: 53002-1310_8e9126f4-3e1f-4dab-b6b4-eb03feb62d7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA021433
Marketing category: NDA
Marketing start: 2007-01-29
Marketing end: 0000-00-00
Substance: FLUTICASONE PROPIONATE
Active strength: 110 ug/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	53002-1310		D	Discontinued by firm		2026-08-10
excluded package	package	53002-1310	53002-1310-1	D	Discontinued by firm		2026-08-10

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1310-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1310-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1310-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1310-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1310-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1310-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1310-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1310-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1310-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-1310-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-1310-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-1310-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1310-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1310-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021433-001	FLOVENT HFA	FLUTICASONE PROPIONATE	0.22MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-05-14
N021433-002	FLOVENT HFA	FLUTICASONE PROPIONATE	0.11MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-05-14
N021433-003	FLOVENT HFA	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2004-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021433-003	AB

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 4 · 123 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	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021433-002	FLOVENT HFA	0.11MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021433-003	FLOVENT HFA	0.044MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021433-001	FLOVENT HFA	0.22MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2004-05-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021433-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 400 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021433-001	7500444	2026-02-26	Drug product, Delist requested	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021433-001	7500444*PED	2026-08-26	Pediatric extension	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021433-002	7500444	2026-02-26	Drug product, Delist requested	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021433-002	7500444*PED	2026-08-26	Pediatric extension	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-06-07	These highlights do not include all the information needed to use FLOVENT HFA safely and effectively. See full prescribing information for FLOVENT HFA. FLOVENT HFA (fluticasone propionate inhalation aerosol), for oral inhalation use Initial U.S. Approval: 1994
2023-01-30	These highlights do not include all the information needed to use FLOVENT HFA safely and effectively. See full prescribing information for FLOVENT HFA. FLOVENT HFA (fluticasone propionate inhalation aerosol), for oral inhalation use Initial U.S. Approval: 1994
2020-12-15	These highlights do not include all the information needed to use FLOVENT HFA safely and effectively. See full prescribing information for FLOVENT HFA. FLOVENT HFA (fluticasone propionate inhalation aerosol), for oral inhalation use Initial U.S. Approval: 1994
2020-01-31	These highlights do not include all the information needed to use FLOVENT HFA safely and effectively. See full prescribing information for FLOVENT HFA. FLOVENT HFA (fluticasone propionate inhalation aerosol), for oral inhalation use Initial U.S. Approval: 1994

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 HFA	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals Inc.	ff1cf174-ae6f-45f0-a081-26a34e55f9ea	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021433 application number: NDA021433
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	faaa1436-dafb-4f65-b062-b51b902f43c5	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021433 application number: NDA021433
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	674b1c81-359d-4fc4-8ce6-a53931b171e0	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021433 application number: NDA021433
FLOVENT HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	74563f7b-8512-4b76-8c55-b88b9cd3206b	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021433 application number: NDA021433
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021433 application number: NDA021433
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	Prasco Laboratories	99249b31-bf0a-464f-8335-845279350dbe	2023-09-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021433 application number: NDA021433

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1310-1	53002131001	1 INHALER in 1 CARTON (53002-1310-1) > 120 AEROSOL, METERED in 1 INHALER	1 inhaler	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLOVENT HFA - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5