Maxidex

Product NDC: 0998-0615
Requested package NDC: 0998-0615-05
11-digit product format: 009980615
Labeler code: 0998
Product ID: 0998-0615_b8c236f1-ed27-4d57-9ffd-62941ff8c7e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: SUSPENSION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA013422
Marketing category: NDA
Marketing start: 1966-05-15
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 1 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0998-0615	0998-0615-05	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 · 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 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
N013422-001	MAXIDEX	DEXAMETHASONE	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013422-001	MAXIDEX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0998-0615-04	Maxidex	5 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	5	1
0998-0615-05	Maxidex	5 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	5	1
0998-0615-06	Maxidex	5 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	5	1
0998-0615-15	Maxidex	15 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	15	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0998-0615-05	ML - Milliliter	0998-0615	25e1e147-7af3-4842-b34a-a7310b825a23	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	2
dexamethasone	ACTIVE INGREDIENT	7S5I7G3JQL	MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
dexamethasone	ACTIVE MOIETY	7S5I7G3JQL	MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
benzalkonium chloride	INACTIVE INGREDIENT		MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
citric acid and/or sodium hydroxide	INACTIVE INGREDIENT		MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
dibasic sodium phosphate	INACTIVE INGREDIENT	GR686LBA74	MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
hypromellose	INACTIVE INGREDIENT		MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
polysorbate 80	INACTIVE INGREDIENT		MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0998-0615	MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]	1	Legacy NDC, 4 package rows	20080313_a0aa9dc9-265c-4dd6-9b03-276a47217839.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAXIDEX	DEXAMETHASONE	Harrow Eye, LLC	35e47fcd-e020-43e5-8322-41f8060d220d	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 013422 application number: NDA013422

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309692	dexAMETHasone 0.1 % Ophthalmic Suspension	PSN	a0aa9dc9-265c-4dd6-9b03-276a47217839	1
205669	Maxidex 0.1 % Ophthalmic Suspension	PSN	a0aa9dc9-265c-4dd6-9b03-276a47217839	1
205669	dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]	SBD	a0aa9dc9-265c-4dd6-9b03-276a47217839	1
309692	dexamethasone 1 MG/ML Ophthalmic Suspension	SCD	a0aa9dc9-265c-4dd6-9b03-276a47217839	1
309692	dexamethasone 0.1 % Ophthalmic Suspension	SY	a0aa9dc9-265c-4dd6-9b03-276a47217839	1
205669	Maxidex 0.1 % Ophthalmic Suspension	SY	a0aa9dc9-265c-4dd6-9b03-276a47217839	1
205669	Maxidex 1 MG/ML Ophthalmic Suspension	SY	a0aa9dc9-265c-4dd6-9b03-276a47217839	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0998-0615-05	00998061505	5 mL in 1 BOTTLE, PLASTIC (0998-0615-05)	5 ml	1966-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maxidex ® (dexamethasone ophthalmic suspension) 0.1% Sterile	Alcon Laboratories, Inc.	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	12
Maxidex® 0.1% (dexamethasone ophthalmic suspension) Sterile	ALCON LABORATORIES, INC.	2006-08-21	Human Prescription Drug Label	1