Flarex

Product NDC: 0065-0096
11-digit product format: 000650096
Labeler code: 0065
Product ID: 0065-0096_a8be38a7-2eb3-4b53-86ec-7ccc69d19f10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluorometholone acetate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA019079
Marketing category: NDA
Marketing start: 1992-02-06
Marketing end: 0000-00-00
Substance: FLUOROMETHOLONE ACETATE
Active strength: 1 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0065-0096		D	Discontinued by firm		2026-08-03
excluded package	package	0065-0096	0065-0096-05	D	Discontinued by firm		2026-08-03

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 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-0096-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-0096-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-0096-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-0096-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-0096-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-0096-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-0096-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-0096-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-0096-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-0096-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-0096-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-0096-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0065-0096-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0065-0096-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0065-0096-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0065-0096-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0065-0096-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0065-0096-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0065-0096-05	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019079-001	FLAREX	FLUOROMETHOLONE ACETATE	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1986-02-11

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0065-0096-05	2025-12-31	C162847	48780-1	ba0f9c33-54aa-a910-e053-dadaa90a0b85	Flarex ® (fluorometholone acetate ophthalmic suspension) 0.1% Sterile
0065-0096-05	2021-01-29	C162847	48780-1	ba0f9c33-54aa-a910-e053-dadaa90a0b85	Flarex ® (fluorometholone acetate ophthalmic suspension) 0.1% Sterile

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0096-05	ML - Milliliter	0065-0096	87d1964c-03fd-49ca-8a97-cb1d1019bd08	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOROMETHOLONE ACETATE	ACTIVE INGREDIENT	9I50C3I3OK	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
FLUOROMETHOLONE	ACTIVE MOIETY	SV0CSG527L	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION [ALCON LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0096	FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	11	Legacy NDC	20200101_6ae122c0-eb4f-4124-96d7-ba5e9a350d35.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flarex	FLUOROMETHOLONE ACETATE	Harrow Eye, LLC	f060dec4-09dc-4266-ab4c-a6ed49cd8126	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019079 application number: NDA019079
Flarex	FLUOROMETHOLONE ACETATE	Eyevance Pharmaceuticals	19918ea5-8568-44d6-b8ee-7b2197cee85c	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019079 application number: NDA019079

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9I50C3I3OK	FLUOROMETHOLONE ACETATE	3801-06-7	FLUOROMETHOLONE ACETATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flarex ® (fluorometholone acetate ophthalmic suspension) 0.1% Sterile	Alcon Laboratories, Inc. \| Alcon Research LLC	2016-10-10	HUMAN PRESCRIPTION DRUG LABEL	11