Home NDC 11980-211 FML
Product NDC 11980-211
11-digit product format 119800211
Labeler code 11980
Product ID 11980-211_000b0dad-a290-4a62-81ec-208e0a9c058b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorometholone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application NDA016851
Marketing category NDA
Marketing start 1972-02-01
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 N016851-002 FML FLUOROMETHOLONE 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N016851-002 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.
Product history page 1 of 2 · 42 observed 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 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1982-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N016851-002 FML 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1982-07-28 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base FML
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310377 Internal RxNorm lookup 545243 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 11980-211-05 FML 1 in 1 CARTON SUSPENSION/ DROPS 1 14 11980-211-05 FML 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 14 11980-211-10 FML 1 in 1 CARTON SUSPENSION/ DROPS 1 14 11980-211-10 FML 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded fluorometholone ACTIVE INGREDIENT SV0CSG527L FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 fluorometholone ACTIVE MOIETY SV0CSG527L FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 edetate disodium INACTIVE INGREDIENT 7FLD91C86K FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 sodium chloride INACTIVE INGREDIENT 451W47IQ8X FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5 water INACTIVE INGREDIENT 059QF0KO0R FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11980-211 FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 13 Current NDC, Legacy NDC, 4 package rows 20241108_c374d65a-35b5-4c9e-9069-5148875dc4df.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 Marketing start Marketing end Sample Exclude flag Status 11980-211-05 11980021105 1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER 1972-02-01 0000-00-00 No No Current 11980-211-10 11980021110 1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER 1972-02-01 0000-00-00 No No Current