Home NDC 60758-880 FLUOROMETHOLONE
Product NDC 60758-880
11-digit product format 607580880
Labeler code 60758
Product ID 60758-880_6dbbb0d9-cddb-4634-8273-e70e54ea4a38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorometholone
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Pacific Pharma, Inc.
Application NDA016851
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1997-10-31
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 60758-880-05 FLUOROMETHOLONE 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 10 60758-880-05 FLUOROMETHOLONE 1 in 1 CARTON SOLUTION/ DROPS 1 10 60758-880-10 FLUOROMETHOLONE 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 10 60758-880-10 FLUOROMETHOLONE 1 in 1 CARTON SOLUTION/ DROPS 1 10 60758-880-15 FLUOROMETHOLONE 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 10 60758-880-15 FLUOROMETHOLONE 1 in 1 CARTON SOLUTION/ DROPS 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded fluorometholone ACTIVE INGREDIENT SV0CSG527L FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 fluorometholone ACTIVE MOIETY SV0CSG527L FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 edetate disodium INACTIVE INGREDIENT 7FLD91C86K FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 sodium chloride INACTIVE INGREDIENT 451W47IQ8X FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60758-880 FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 9 Current NDC, Legacy NDC, 6 package rows 20231114_af59c420-789d-4c05-b3fc-c3f855bcac24.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 Units Marketing start Marketing end Sample Exclude flag Status 60758-880-05 60758088005 1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER 1997-10-31 0000-00-00 No No Current 60758-880-10 60758088010 1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER 1997-10-31 0000-00-00 No No Current 60758-880-15 60758088015 15 mL in 1 BOTTLE, DROPPER 15 ml Historical