Home NDC 62332-750 Difluprednate
Product NDC 62332-750
11-digit product format 623320750
Labeler code 62332
Product ID 62332-750_47a98642-28a5-4661-86ff-72ed6a819300
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name difluprednate ophthalmic
Dosage form EMULSION
Route OPHTHALMIC
Labeler Alembic Pharmaceuticals Inc.
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62332-750-05 Difluprednate 5 mL in 1 BOTTLE EMULSION 5 5 62332-750-05 Difluprednate 1 in 1 CARTON EMULSION 1 5
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Difluprednate DIFLUPREDNATE OPHTHALMIC Alembic Pharmaceuticals Limited 71121026-1496-4154-b61b-9afe9b62bf2a 2026-01-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 213774 application number: ANDA213774
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62332-750-05 62332075005 1 BOTTLE in 1 CARTON (62332-750-05) / 5 mL in 1 BOTTLE 1 bottle 2026-01-26 No No Current