DUREZOL

Product NDC: 0078-0862
11-digit product format: 000780862
Labeler code: 0078
Product ID: 0078-0862_830dd64e-8b1a-4bc4-86bd-e0a0915b59e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: difluprednate
Dosage form: EMULSION
Route: OPHTHALMIC
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA022212
Marketing category: NDA
Marketing start: 2011-01-25
Marketing end: 0000-00-00
Substance: DIFLUPREDNATE
Active strength: 1 mg/mL
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	0078-0862		D	Discontinued by firm		2026-10-05
excluded package	package	0078-0862	0078-0862-25	D	Discontinued by firm		2026-10-05

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	0078-0862		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0078-0862	0078-0862-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
N022212-001	DUREZOL	DIFLUPREDNATE	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022212-001	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	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2008-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022212-001	DUREZOL	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2008-06-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022212-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022212-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022212-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022212-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022212-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022212-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022212-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022212-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022212-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022212-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022212-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022212-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022212-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022212-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022212-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022212-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022212-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022212-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022212-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022212-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022212-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022212-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022212-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022212-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022212-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022212-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022212-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022212-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022212-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022212-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022212-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022212-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022212-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022212-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022212-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022212-001	6114319	2019-05-18	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022212-001	6114319*PED	2019-11-18	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022212-001	6114319	2019-05-18	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022212-001	6114319*PED	2019-11-18	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022212-001	6114319	2019-05-18	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022212-001	6114319*PED	2019-11-18	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022212-001	6114319	2019-05-18	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022212-001	6114319*PED	2019-11-18	Pediatric extension	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022212-001	ODE-26	2019-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022212-001	PED	2019-12-13	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022212-001	ODE-26	2019-06-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022212-001	PED	2019-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022212-001	ODE-26	2019-06-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022212-001	PED	2019-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022212-001	ODE-26	2019-06-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022212-001	PED	2019-12-13	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0862-25	ML - Milliliter	0078-0862	988f3d5c-df6d-4cad-b039-bb7ed412087b	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0862	DUREZOL (DIFLUPREDNATE) EMULSION [NOVARTIS PHARMACEUTICALS CORPORATION]	2	Legacy NDC	20230628_830dd64e-8b1a-4bc4-86bd-e0a0915b59e7.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
Difluprednate Ophthalmic	DIFLUPREDNATE OPHTHALMIC	Sandoz Inc	0f60b857-7898-4a9e-935c-a9ddf0eb9194	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022212 application number: NDA022212
DUREZOL	DIFLUPREDNATE	Sandoz Inc	ea520a27-f569-4b31-8bad-a25ad54b2caa	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022212 application number: NDA022212

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0862-25	00078086225	1 BOTTLE in 1 CARTON (0078-0862-25) > 5 mL in 1 BOTTLE	1 bottle	2022-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DUREZOL - Novartis Pharmaceuticals Corporation	Novartis Pharmaceuticals Corporation	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	4