Home NDC 0378-7518 Difluprednate
Product NDC 0378-7518
11-digit product format 003787518
Labeler code 0378
Product ID 0378-7518_4cd854c9-acfa-4594-9f79-5d33ae0b84c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Difluprednate
Dosage form EMULSION
Route OPHTHALMIC
Labeler Mylan Pharmaceuticals Inc.
Application ANDA212566
Marketing category ANDA
Marketing start 2025-09-26
Marketing end 2027-06-30
Substance DIFLUPREDNATE
Active strength .5 mg/mL
NDC exclude flag No
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 A212566-001 DIFLUPREDNATE DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2025-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212566-001 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 A212566-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2025-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212566-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2025-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212566-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2025-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212566-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2025-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212566-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2025-03-20 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212566-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2025-03-20 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 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 0378-7518-35 Difluprednate 5 mL in 1 BOTTLE EMULSION 5 2 0378-7518-35 Difluprednate 1 in 1 CARTON EMULSION 1 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-7518-35 00378751835 1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE 1 bottle 2025-09-26 2027-06-30 No No Historical