Maxidex

Product NDC
0998-0615
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0998-0615DDiscontinued by firm2026-08-03
excluded packagepackage0998-06150998-0615-05DDiscontinued by firm2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0998-0615-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0998-0615-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0998-0615-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0998-0615-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0998-0615-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0998-0615-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0998-0615-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0998-0615-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0998-0615-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0998-0615-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0998-0615-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0998-0615-05557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N013422-001MAXIDEXDEXAMETHASONE0.1%SUSPENSION/DROPS / OPHTHALMICRLD, 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N013422-001MAXIDEX0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS, Approved before 1982cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0998-0615-04Maxidex5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS51
0998-0615-05Maxidex5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS51
0998-0615-06Maxidex5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS51
0998-0615-15Maxidex15 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0998-0615-05ML - Milliliter0998-061525e1e147-7af3-4842-b34a-a7310b825a2312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74MAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMAXIDEX (DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]2
dexamethasoneACTIVE INGREDIENT7S5I7G3JQLMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
dexamethasoneACTIVE MOIETY7S5I7G3JQLMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
benzalkonium chlorideINACTIVE INGREDIENTMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
citric acid and/or sodium hydroxideINACTIVE INGREDIENTMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
dibasic sodium phosphateINACTIVE INGREDIENTGR686LBA74MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
hypromelloseINACTIVE INGREDIENTMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
polysorbate 80INACTIVE INGREDIENTMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RMAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0998-0615MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]1Legacy NDC, 4 package rows20080313_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIDEXDEXAMETHASONEHarrow Eye, LLC35e47fcd-e020-43e5-8322-41f8060d220d2025-05-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 013422
application number: NDA013422

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309692dexAMETHasone 0.1 % Ophthalmic SuspensionPSNa0aa9dc9-265c-4dd6-9b03-276a472178391
205669Maxidex 0.1 % Ophthalmic SuspensionPSNa0aa9dc9-265c-4dd6-9b03-276a472178391
205669dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]SBDa0aa9dc9-265c-4dd6-9b03-276a472178391
309692dexamethasone 1 MG/ML Ophthalmic SuspensionSCDa0aa9dc9-265c-4dd6-9b03-276a472178391
309692dexamethasone 0.1 % Ophthalmic SuspensionSYa0aa9dc9-265c-4dd6-9b03-276a472178391
205669Maxidex 0.1 % Ophthalmic SuspensionSYa0aa9dc9-265c-4dd6-9b03-276a472178391
205669Maxidex 1 MG/ML Ophthalmic SuspensionSYa0aa9dc9-265c-4dd6-9b03-276a472178391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0998-0615-04009980615045 mL in 1 BOTTLE, PLASTIC5 mlHistorical
0998-0615-05009980615055 mL in 1 BOTTLE, PLASTIC (0998-0615-05) 5 ml1966-05-150000-00-00NoNoCurrent
0998-0615-06009980615065 mL in 1 BOTTLE, PLASTIC5 mlHistorical
0998-0615-150099806151515 mL in 1 BOTTLE, PLASTIC15 mlHistorical