Fluticasone Propionate

Product NDC: 10544-653
11-digit product format: 105440653
Labeler code: 10544
Product ID: 10544-653_13f0f08b-8311-2949-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluticasone Propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA077538
Marketing category: ANDA
Marketing start: 2007-09-19
Marketing end: 0000-00-00
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	10544-653		I	Inactivated by FDA		2026-08-10
excluded package	package	10544-653	10544-653-99	I	Inactivated by FDA		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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-653-99	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-653-99	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-653-99	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-653-99	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-653-99	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-653-99	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-653-99	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-653-99	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-653-99	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-653-99	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-653-99	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-653-99	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-653-99	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-653-99	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-653-99	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-653-99	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-653-99	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-653-99	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-653-99	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	10544-653-99	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	10544-653-99	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10544-653-99	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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
A077538-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB		2007-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077538-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077538-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077538-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077538-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077538-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077538-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077538-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077538-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077538-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077538-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077538-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077538-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077538-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077538-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077538-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077538-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077538-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077538-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077538-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077538-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077538-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077538-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077538-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077538-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077538-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077538-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077538-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077538-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077538-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077538-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077538-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077538-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077538-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077538-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077538-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077538-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077538-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077538-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077538-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077538-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077538-001	AB	1	`cb3db0bc1861…`

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-653-99	2020-01-31	C162847	48780-1	9d75b9d1-2040-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FLUTICASONE propionate safely and effectively. See full prescribing information for FLUTICASONE propionate. FLUTICASONE propionate nasal spray, USP, 50 mcg FOR INTRANASAL USE Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-653-99	Fluticasone Propionate	120 in 1 BOTTLE, SPRAY	SPRAY, METERED	120		1
10544-653-99	Fluticasone Propionate	1 in 1 CARTON	SPRAY, METERED	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUTICASONE PROPIONATE	ACTIVE INGREDIENT	O2GMZ0LF5W	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
FLUTICASONE	ACTIVE MOIETY	CUT2W21N7U	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
PHENYLETHYL ALCOHOL	INACTIVE INGREDIENT	ML9LGA7468	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-653	FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20150418_13f0f08b-8310-2949-e054-00144ff88e88.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals, Inc.	4916301d-bcc8-4cd1-86b4-7bf0aecfbf68	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	Direct_RX	8b9f7474-8d89-b3e6-e053-2995a90aeddb	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	IPG Pharmaceuticals, Inc.	f1965bd9-1851-4be5-bbe0-71dd59e034d5	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	REMEDYREPACK INC.	d781dd49-ed8d-4204-99ac-a3b632d7640a	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	Golden State Medical Supply, Inc.	db857d81-4b1e-42b8-972a-5bb8735d60f8	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	Apotex Corp.	3830675d-b45e-fc97-1f73-674b1fc38c80	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	504397c5-6f9f-45cc-9cc9-997da0a80364	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	Quality Care Products, LLC	1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	Proficient Rx LP	1d5d5f27-6565-4e7b-9923-faa3d15cb1c4	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	e2df3810-3b92-4678-8f62-683c656b1de9	2023-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538

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
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	13f0f08b-8310-2949-e054-00144ff88e88	1
1797907	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	13f0f08b-8310-2949-e054-00144ff88e88	1
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	13f0f08b-8310-2949-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-653-99	10544065399	120 in 1 BOTTLE, SPRAY	Historical