Home NDC 60219-1586 fluorometholone ophthalmic suspension
Product NDC 60219-1586
11-digit product format 602191586
Labeler code 60219
Product ID 60219-1586_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorometholone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA216348
Marketing category ANDA
Marketing start 2023-01-09
Substance FLUOROMETHOLONE
Active strength 1 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 42 .
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 A216348-001 FLUOROMETHOLONE FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216348-001 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 2026-08-18 06:07:40 2026-07 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216348-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-01-09 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216348-001 CGT 2024-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216348-001 CGT 2024-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216348-001 CGT 2024-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216348-001 CGT 2024-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216348-001 CGT 2024-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216348-001 CGT 2024-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216348-001 CGT 2024-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216348-001 CGT 2024-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216348-001 CGT 2024-07-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216348-001 CGT 2024-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216348-001 CGT 2024-07-07 1c564ffb4f44…
Additional Listing Data#
Finished product Yes
Brand name base fluorometholone ophthalmic suspension
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROMETHOLONE 1 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60219-1586-6 fluorometholone ophthalmic suspension 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 6 60219-1586-6 fluorometholone ophthalmic suspension 1 in 1 CARTON SUSPENSION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1586 FLUOROMETHOLONE OPHTHALMIC SUSPENSION (FLUOROMETHOLONE) SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC] 6 Current NDC, 2 package rows 20240112_e7988a3b-e432-4d42-a8d2-63ca017e6a01.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 Marketing start Sample Exclude flag Status 60219-1586-6 60219158606 1 BOTTLE, DROPPER in 1 CARTON (60219-1586-6) / 10 mL in 1 BOTTLE, DROPPER 2023-01-09 No No Current