Home NDC 0781-6000 Difluprednate Ophthalmic
Product NDC 0781-6000
11-digit product format 007816000
Labeler code 0781
Product ID 0781-6000_a0888296-a4c5-4392-a2a9-98770f6b179a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Difluprednate Ophthalmic
Dosage form EMULSION
Route OPHTHALMIC
Labeler Sandoz Inc
Application NDA022212
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-05-15
Substance DIFLUPREDNATE
Active strength .5 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date 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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Difluprednate Ophthalmic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIFLUPREDNATE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S8A06QG2QE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 804544 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-6000-78 Difluprednate Ophthalmic 1 in 1 CARTON EMULSION 1 4 0781-6000-78 Difluprednate Ophthalmic 5 mL in 1 BOTTLE EMULSION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-6000 DIFLUPREDNATE OPHTHALMIC EMULSION [SANDOZ INC] 3 Current NDC, Legacy NDC, 2 package rows 20220702_0f60b857-7898-4a9e-935c-a9ddf0eb9194.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-6000-78 00781600078 1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE 1 bottle 2021-09-15 0000-00-00 No No Current