Diflorasone Diacetate

Product NDC: 72919-549
11-digit product format: 729190549
Labeler code: 72919
Product ID: 72919-549_b1da7022-1876-4413-8115-5d39c32bc7c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diflorasone Diacetate
Dosage form: CREAM
Route: TOPICAL
Labeler: Emerald Therapeutics, LLC
Application: ANDA075508
Marketing category: ANDA
Marketing start: 2000-04-24
Marketing end: 0000-00-00
Substance: DIFLORASONE DIACETATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	72919-549		D	Discontinued by firm		2026-08-17
excluded package	package	72919-549	72919-549-60	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	72919-549		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72919-549	72919-549-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075508-001	DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075508-001	BX

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 · 42 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
2026-08-18 06:07:40	2026-07	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075508-001	DIFLORASONE DIACETATE	0.05%	CREAM / TOPICAL	BX	RS	2000-04-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075508-001	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075508-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075508-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075508-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075508-001	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075508-001	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075508-001	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075508-001	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075508-001	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075508-001	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075508-001	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075508-001	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075508-001	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075508-001	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075508-001	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075508-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075508-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075508-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075508-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075508-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075508-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075508-001	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075508-001	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075508-001	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075508-001	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075508-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075508-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075508-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075508-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075508-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075508-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075508-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075508-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075508-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075508-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075508-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075508-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075508-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075508-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075508-001	BX	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72919-549-60	GM - Gram	72919-549	27fd2ad8-1bdc-450b-81bc-4a28c8e9d843	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72919-549	DIFLORASONE DIACETATE CREAM [EMERALD THERAPEUTICS, LLC]	1	Legacy NDC	20211007_37c946b4-bf1a-4b10-b90d-eec81a5989d9.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
Diflorasone Diacetate	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	b20c9420-8fb4-4a49-93f0-c0e4074d6d71	2025-09-22	Adverse reactions	Exact identifier application applno (ANDA): 075508 application number: ANDA075508
psorcon	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	de40cc65-f955-423f-9cbd-bc2245c4f982	2025-07-02	Adverse reactions	Exact identifier application applno (ANDA): 075508 application number: ANDA075508

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7W2J09SCWX	DIFLORASONE DIACETATE	33564-31-7	DIFLORASONE DIACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72919-549-60	72919054960	1 TUBE in 1 CARTON (72919-549-60) > 60 g in 1 TUBE	1 tube	2021-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diflorasone Diacetate Cream USP, 0.05%	Emerald Therapeutics, LLC	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	2