DIFLUPREDNATE

Product NDC: 76282-708
Requested package NDC: 76282-708-50
11-digit product format: 762820708
Labeler code: 76282
Product ID: 76282-708_8cddb271-2bf9-4493-b5cf-547f56c46caf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIFLUPREDNATE
Dosage form: EMULSION
Route: OPHTHALMIC
Labeler: Exelan Pharmaceuticals, Inc.
Application: ANDA211776
Marketing category: ANDA
Marketing start: 2021-12-10
Marketing end: 0000-00-00
Substance: DIFLUPREDNATE
Active strength: 1 mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76282-708	76282-708-50	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A211776-001	DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB		2021-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211776-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211776-001	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	2021-08-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211776-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211776-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211776-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211776-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211776-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211776-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211776-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211776-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211776-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211776-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211776-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211776-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211776-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211776-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211776-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211776-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211776-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211776-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211776-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211776-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211776-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211776-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211776-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211776-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211776-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211776-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211776-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211776-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211776-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211776-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211776-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211776-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211776-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211776-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
05bd5167-c8bb-b60b-f647-c2bfd6944eb3	Product name	5	20260107
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76282-708-50	2024-01-30	C162847	48780-1	1030e365-6e4f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DIFLUPREDNATE OPHTHALMIC EMULSION safely and effectively. See full prescribing information for DIFLUPREDNATE OPHTHALMIC EMULSION.<BR><BR>DIFLUPREDNATE ophthalmic emulsion 0.05%<BR>Initial U.S. approval: 2008<BR>

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76282-708-50	DIFLUPREDNATE	5 mL in 1 BOTTLE	EMULSION	5		1
76282-708-50	DIFLUPREDNATE	1 in 1 CARTON	EMULSION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-708-50	ML - Milliliter	76282-708	6c4ce2e6-4b83-478b-a1a5-317e72ffe2c2	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-708	DIFLUPREDNATE EMULSION [EXELAN PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20211212_f7744cc9-bc5b-4642-8b36-07136704910a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIFLUPREDNATE	DIFLUPREDNATE	Cipla USA Inc.	8a7254de-a7a2-476d-9295-c41926267ec9	2020-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211776 application number: ANDA211776

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S8A06QG2QE	DIFLUPREDNATE	23674-86-4	DIFLUPREDNATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
804544	difluprednate 0.05 % Ophthalmic Emulsion	PSN	f7744cc9-bc5b-4642-8b36-07136704910a	1
804544	difluprednate 0.5 MG/ML Ophthalmic Suspension	SCD	f7744cc9-bc5b-4642-8b36-07136704910a	1
804544	difluprednate 0.05 % Ophthalmic Emulsion	SY	f7744cc9-bc5b-4642-8b36-07136704910a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-708-50	76282070850	1 BOTTLE in 1 CARTON (76282-708-50) > 5 mL in 1 BOTTLE	1 bottle	2021-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIFLUPREDNATE - Exelan Pharmaceuticals, Inc. \| Cipla USA Inc. \| Farmabios S.p.A.	Exelan Pharmaceuticals, Inc. \| Cipla USA Inc. \| Farmabios S.p.A.	2021-12-10	HUMAN PRESCRIPTION DRUG LABEL	1