Dexamethasone Sodium Phosphate

Product NDC
42254-088
11-digit product format
422540088
Labeler code
42254
Product ID
42254-088_b61aec30-66c0-4abe-a8ad-2d98d88f21b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA040069
Marketing category
ANDA
Marketing start
1996-07-26
Marketing end
0000-00-00
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct42254-088IInactivated by FDA2026-08-03
excluded packagepackage42254-08842254-088-05IInactivated by FDA2026-08-03

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 · 44 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 packagepackage42254-088-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-088-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-088-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-088-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-088-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-088-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-088-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-088-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-088-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-088-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-088-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-088-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-088-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-088-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-088-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-088-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-088-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-088-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-088-058dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-088-05e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-088-059bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-088-05110d247fa046…a55b01930146…

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
A040069-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26

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 UTC2026-02A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-088-052019-09-24C16284748780-19350213a-3dee-c013-e053-90daa90a1393Dexamethasone Sodium Phosphate Ophthalmic Solution USP, 0.1% Dexamethasone Phosphate Equivalent (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-088-05Dexamethasone Sodium Phosphate1 in 1 CARTONSOLUTION/ DROPS11
42254-088-05Dexamethasone Sodium Phosphate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-088-05ML - Milliliter42254-088538291e5-84e3-4fa1-9d92-534c15da209b12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-088DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120426_b61aec30-66c0-4abe-a8ad-2d98d88f21b8.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
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEBausch & Lomb Incorporated6bdcefbe-51e3-4ca4-afda-5aeca7b6fa732022-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040069
application number: ANDA040069

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226343dexAMETHasone sodium phosphate 0.1 % Ophthalmic SolutionPSNb61aec30-66c0-4abe-a8ad-2d98d88f21b81
226343dexamethasone phosphate 1 MG/ML Ophthalmic SolutionSCDb61aec30-66c0-4abe-a8ad-2d98d88f21b81
226343dexamethasone sodium phosphate 0.1 % Ophthalmic SolutionSYb61aec30-66c0-4abe-a8ad-2d98d88f21b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-088-05422540088051 in 1 CARTONHistorical