Home NDC 65145-161 Difluprednate
Product NDC 65145-161
11-digit product format 651450161
Labeler code 65145
Product ID 65145-161_0f9a1987-6a04-4764-94e5-7053997c058b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Difluprednate
Dosage form EMULSION
Route OPHTHALMIC
Labeler Caplin Steriles Limited
Application ANDA219441
Marketing category ANDA
Marketing start 2024-12-26
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 A219441-001 DIFLUPREDNATE DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219441-001 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 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219441-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2024-12-13 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
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 65145-161-01 Difluprednate 5 mL in 1 BOTTLE EMULSION 5 1 65145-161-01 Difluprednate 1 in 1 CARTON EMULSION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65145-161 DIFLUPREDNATE EMULSION [CAPLIN STERILES LIMITED] 1 Current NDC, 2 package rows 20241228_0f9a1987-6a04-4764-94e5-7053997c058b.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 Sample Exclude flag Status 65145-161-01 65145016101 1 BOTTLE in 1 CARTON (65145-161-01) / 5 mL in 1 BOTTLE 1 bottle 2024-12-26 No No Current