Home NDC 43598-588 Difluprednate Ophthalmic Emulsion
Product NDC 43598-588
11-digit product format 435980588
Labeler code 43598
Product ID 43598-588_acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Difluprednate Ophthalmic
Dosage form EMULSION
Route OPHTHALMIC
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA214894
Marketing category ANDA
Marketing start 2022-12-25
Substance DIFLUPREDNATE
Active strength .5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 A214894-001 DIFLUPREDNATE DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214894-001 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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214894-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2022-11-16 a50c72e98297…
Observed Orange Book normalized TE 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 Emulsion
Listing expiration 2026-12-31 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 43598-588-11 Difluprednate Ophthalmic Emulsion 5 mL in 1 BOTTLE EMULSION 5 6 43598-588-11 Difluprednate Ophthalmic Emulsion 1 in 1 CARTON EMULSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-588 DIFLUPREDNATE OPHTHALMIC EMULSION (DIFLUPREDNATE OPHTHALMIC) EMULSION [DR. REDDY'S LABORATORIES INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250112_12803630-3196-1b3e-28e4-a598a742ef1a.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.
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 43598-588-11 43598058811 1 BOTTLE in 1 CARTON (43598-588-11) / 5 mL in 1 BOTTLE 1 bottle 2022-12-25 0000-00-00 No No Current