MAXIDEX

Product NDC: 82667-600
11-digit product format: 826670600
Labeler code: 82667
Product ID: 82667-600_34661206-e37a-6ce7-e063-6394a90aaf85
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: FOR SUSPENSION
Route: OPHTHALMIC
Labeler: Harrow Eye, LLC
Application: NDA013422
Marketing category: NDA
Marketing start: 2025-04-07
Substance: DEXAMETHASONE
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: MAXIDEX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7S5I7G3JQL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205669	Internal RxNorm lookup
309692	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
35e47fcd-e020-43e5-8322-41f8060d220d	Available on FDA.report

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	Strength	SPL version
82667-600-05	MAXIDEX	5 mL in 1 BOTTLE, PLASTIC	FOR SUSPENSION	5		2
82667-600-05	MAXIDEX	1 in 1 CARTON	FOR SUSPENSION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82667-600-05	ML - Milliliter	82667-600	a867a4e9-0151-4eba-a8e3-a079ce26ca67	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82667-600	MAXIDEX (DEXAMETHASONE) FOR SUSPENSION [HARROW EYE, LLC]	2	Current NDC, 2 package rows	20250507_35e47fcd-e020-43e5-8322-41f8060d220d.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 ndc (product): 82667-600

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	35e47fcd-e020-43e5-8322-41f8060d220d	2
205669	Maxidex 0.1 % Ophthalmic Suspension	PSN	35e47fcd-e020-43e5-8322-41f8060d220d	2
205669	dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]	SBD	35e47fcd-e020-43e5-8322-41f8060d220d	2
309692	dexamethasone 1 MG/ML Ophthalmic Suspension	SCD	35e47fcd-e020-43e5-8322-41f8060d220d	2
309692	dexamethasone 0.1 % Ophthalmic Suspension	SY	35e47fcd-e020-43e5-8322-41f8060d220d	2
205669	Maxidex 0.1 % Ophthalmic Suspension	SY	35e47fcd-e020-43e5-8322-41f8060d220d	2
205669	Maxidex 1 MG/ML Ophthalmic Suspension	SY	35e47fcd-e020-43e5-8322-41f8060d220d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82667-600-05	82667060005	1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05) / 5 mL in 1 BOTTLE, PLASTIC	2025-04-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maxidex ® (dexamethasone ophthalmic suspension) 0.1% Sterile	Harrow Eye, LLC	2025-05-05	HUMAN PRESCRIPTION DRUG LABEL	2