Home NDC 46708-750 Difluprednate
Product NDC 46708-750
11-digit product format 467080750
Labeler code 46708
Product ID 46708-750_71121026-1496-4154-b61b-9afe9b62bf2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name difluprednate ophthalmic
Dosage form EMULSION
Route OPHTHALMIC
Labeler Alembic Pharmaceuticals Limited
Application ANDA213774
Marketing category ANDA
Marketing start 2026-01-26
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 A213774-001 DIFLUPREDNATE DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2026-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213774-001 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 A213774-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2026-01-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213774-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2026-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213774-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2026-01-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213774-001 DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB 2026-01-26 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 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 46708-750-05 Difluprednate 1 in 1 CARTON EMULSION 1 1 46708-750-05 Difluprednate 5 mL in 1 BOTTLE EMULSION 5 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 · 1 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 46708-750-05 46708075005 1 BOTTLE in 1 CARTON (46708-750-05) / 5 mL in 1 BOTTLE 1 bottle 2026-01-26 No No Current