Home NDC 0781-6187 FML
Product NDC 0781-6187
11-digit product format 007816187
Labeler code 0781
Product ID 0781-6187_4d324ee9-c00e-27ba-e063-6294a90a049c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorometholone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Sandoz Inc
Application ANDA218819
Marketing category ANDA
Marketing start 2026-03-30
Substance FLUOROMETHOLONE
Active strength 1 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 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 A218819-001 FLUOROMETHOLONE FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2026-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218819-001 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 A218819-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2026-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218819-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2026-02-12 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218819-001 FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB 2026-02-12 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A218819-001 AB 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218819-001 AB 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218819-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base fluorometholone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROMETHOLONE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SV0CSG527L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310377 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 0781-6187-70 FML 1 in 1 CARTON SUSPENSION/ DROPS 1 1 0781-6187-70 FML 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 1 0781-6187-75 FML 1 in 1 CARTON SUSPENSION/ DROPS 1 1 0781-6187-75 FML 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0781-6187-70 00781618770 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-70) / 10 mL in 1 BOTTLE, DROPPER 2026-03-30 No No Current 0781-6187-75 00781618775 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-75) / 5 mL in 1 BOTTLE, DROPPER 2026-03-30 No No Current