Fluticasone Propionate

Product NDC: 51407-871
11-digit product format: 514070871
Labeler code: 51407
Product ID: 51407-871_5852b1a7-401d-e06b-e063-6294a90a2530
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluticasone Propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA076504
Marketing category: ANDA
Marketing start: 2006-02-22
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076504-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076504-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076504-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076504-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076504-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076504-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076504-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076504-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076504-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076504-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076504-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076504-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076504-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076504-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076504-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076504-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076504-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076504-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076504-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076504-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076504-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076504-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076504-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076504-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076504-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076504-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076504-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076504-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076504-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076504-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076504-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076504-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076504-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076504-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076504-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076504-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076504-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076504-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076504-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076504-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076504-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076504-001	AB	1	`f41ea6bd6efb…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797907	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
534d78c5-4ba0-4ab1-e063-6294a90a8ff7	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Golden State Medical Supply, Inc.	534d78c5-4ba0-4ab1-e063-6294a90a8ff7	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504 ndc (product): 51407-871
Fluticasone Propionate	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals Inc.	0a3447a1-407c-40a8-99bb-7e9a86eb37df	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	Hikma Pharmaceuticals USA Inc.	0d9a521b-8314-437c-8c9f-f6188f1134fe	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	6e2d11f9-94d8-4434-b46b-8e2fcc9276fb	2025-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	3b1849e1-bd0b-42e4-a4ac-f156dc18604a	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	Proficient Rx LP	ab8c172b-c369-4372-95f9-dd1a28b3982b	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	NuCare Pharmaceuticals,Inc.	8761a5e1-a9cb-0622-e053-2a95a90a3504	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504

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	Marketing start	Sample	Exclude flag	Status
51407-871-12	51407087112	1 BOTTLE, GLASS in 1 CARTON (51407-871-12) / 120 SPRAY, METERED in 1 BOTTLE, GLASS	2026-03-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluticasone Propionate	Golden State Medical Supply, Inc. \| West-Ward Columbus Inc.	2026-08-05	HUMAN PRESCRIPTION DRUG LABEL	3