DUREZOL

Product NDC: 0065-9240
Requested package NDC: 0065-9240-07
11-digit product format: 000659240
Labeler code: 0065
Product ID: 0065-9240_ff961dd4-e9a3-4a20-9a36-62319724d973
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DUREZOL
Dosage form: EMULSION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0065-9240	0065-9240-07	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 · 12 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…`

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
0065-9240-05	ML - Milliliter	0065-9240	05a9c157-6cea-4718-8429-94f99fe38881	1	2012-07-24
0065-9240-07	ML - Milliliter	0065-9240	f10b2ebb-6680-4ff7-b334-4e35ef6f22e8	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIFLUPREDNATE	ACTIVE INGREDIENT	S8A06QG2QE	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
DIFLUPREDNATE	ACTIVE MOIETY	S8A06QG2QE	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
WATER	INACTIVE INGREDIENT	059QF0KO0R	DUREZOL EMULSION [ALCON LABORATORIES, INC.]	20
DIFLUPREDNATE	ACTIVE INGREDIENT	S8A06QG2QE	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
DIFLUPREDNATE	ACTIVE MOIETY	S8A06QG2QE	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
804544	difluprednate 0.05 % Ophthalmic Emulsion	PSN	40ac0711-e2c3-4753-ac58-cb99f558f293	1
804544	difluprednate 0.5 MG/ML Ophthalmic Suspension	SCD	40ac0711-e2c3-4753-ac58-cb99f558f293	1
804544	difluprednate 0.05 % Ophthalmic Emulsion	SY	40ac0711-e2c3-4753-ac58-cb99f558f293	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-9240-07	00065924007	1 BOTTLE in 1 CARTON (0065-9240-07) > 5 mL in 1 BOTTLE	1 bottle	2013-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DUREZOL - Alcon Laboratories, Inc.	Alcon Laboratories, Inc.	2023-06-20	HUMAN PRESCRIPTION DRUG LABEL	31
DUREZOL - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-01-28	HUMAN PRESCRIPTION DRUG LABEL	1