FLUTICASONE

Product NDC: 68788-7788
11-digit product format: 687887788
Labeler code: 68788
Product ID: 68788-7788_f6353aa5-07a9-4f46-afd8-5455823d38b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA078492
Marketing category: ANDA
Marketing start: 2020-10-21
Marketing end: 0000-00-00
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68788-7788		D	Discontinued by firm		2026-08-10
excluded package	package	68788-7788	68788-7788-1	D	Discontinued by firm		2026-08-10

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
A078492-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB		2012-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078492-001	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	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`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	A078492-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078492-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078492-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078492-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078492-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078492-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078492-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078492-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078492-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078492-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078492-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078492-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078492-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078492-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078492-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078492-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078492-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078492-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078492-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078492-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078492-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078492-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078492-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078492-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078492-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078492-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078492-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078492-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078492-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078492-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078492-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078492-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078492-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078492-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078492-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078492-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078492-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078492-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078492-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078492-001	AB	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7788	FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [PREFERRED PHARMACEUTICALS INC.]	5	Legacy NDC	20240502_29e9f228-ee69-4d26-b5db-81b2fd5f1bee.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate spray, metered	FLUTICASONE PROPIONATE	Chartwell RX, LLC	71a2609f-c4b9-49b0-8185-83c20c22e1d6	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078492 application number: ANDA078492
Fluticasone	FLUTICASONE PROPIONATE	NuCare Pharmaceuticals,Inc.	549ff4f2-fa68-3dd8-e054-00144ff8d46c	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078492 application number: ANDA078492

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	Marketing end	Sample	Exclude flag	Status
68788-7788-1	68788778801	1 BOTTLE, SPRAY in 1 BOX (68788-7788-1) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY	2020-10-21	0000-00-00	No	No	Current