FLOVENT

Product NDC: 63187-957
11-digit product format: 631870957
Labeler code: 63187
Product ID: 63187-957_cda6757e-ba20-4c5c-8171-632dd1a875aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Proficient Rx LP
Application: NDA020833
Marketing category: NDA
Marketing start: 2008-10-13
Substance: FLUTICASONE PROPIONATE
Active strength: 100 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 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	RLD / RS	Approval date
N020833-001	FLOVENT DISKUS 50	FLUTICASONE PROPIONATE	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29
N020833-002	FLOVENT DISKUS 100	FLUTICASONE PROPIONATE	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29
N020833-003	FLOVENT DISKUS 250	FLUTICASONE PROPIONATE	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29

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	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: FLOVENT
Brand name suffix: DISKUS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	100 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
896021	Internal RxNorm lookup
896023	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
816e929e-6ba0-437d-80bb-00068419ed53	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
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
63187-957-60	FLOVENTDISKUS	60 in 1 INHALER	POWDER, METERED	60		3
63187-957-60	FLOVENTDISKUS	1 in 1 CARTON	POWDER, METERED	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-957-60	EA - Each	63187-957	7ef66cf9-a685-4bc5-ab85-23cca48fd1a5	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-957	FLOVENT DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 2 package rows	20191105_816e929e-6ba0-437d-80bb-00068419ed53.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 DISKUS	FLUTICASONE PROPIONATE	Sportpharm LLC	348cbd8c-edeb-499c-961d-3aeb5cc2cef1	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	da4e897e-9be1-499a-8889-15398b30ef3b	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	64d669da-559c-40f5-b649-2ce164c211ea	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLOVENT DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	038e6c40-9421-40ef-874b-8f4d7110a74a	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	Prasco Laboratories	44d009ba-d4b8-410f-b2bc-71ab2d05ac9e	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLOVENT DISKUS	FLUTICASONE PROPIONATE	Proficient Rx LP	816e929e-6ba0-437d-80bb-00068419ed53	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833 ndc (product): 63187-957

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896023	Flovent Diskus 100 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	816e929e-6ba0-437d-80bb-00068419ed53	3
896021	fluticasone propionate 100 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	816e929e-6ba0-437d-80bb-00068419ed53	3
896023	60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT Dry Powder Inhaler [Flovent]	SBD	816e929e-6ba0-437d-80bb-00068419ed53	3
896021	60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT Dry Powder Inhaler	SCD	816e929e-6ba0-437d-80bb-00068419ed53	3
896023	60 ACTUAT Flovent 0.1 MG/ACTUAT Dry Powder Inhaler	SY	816e929e-6ba0-437d-80bb-00068419ed53	3
896023	Flovent Diskus 0.1 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	816e929e-6ba0-437d-80bb-00068419ed53	3
896023	Flovent Diskus 100 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	816e929e-6ba0-437d-80bb-00068419ed53	3
896021	fluticasone propionate 0.1 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	816e929e-6ba0-437d-80bb-00068419ed53	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-957-60	63187095760	1 INHALER in 1 CARTON (63187-957-60) / 60 POWDER, METERED in 1 INHALER	1 inhaler	2018-03-01	0000-00-00	No	No	Current