FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
21695-847
11-digit product format
216950847
Labeler code
21695
Product ID
21695-847_a2c2385e-74a8-4a18-92ec-be8a1380e13a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone sodium phosphate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA088771
Marketing category
ANDA
Marketing start
1985-01-16
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 productproduct21695-847IInactivated by FDA2026-08-03
excluded packagepackage21695-84721695-847-05IInactivated 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 packagepackage21695-847-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-847-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-847-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-847-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-847-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-847-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-847-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-847-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-847-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-847-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-847-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-847-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-847-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-847-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-847-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-847-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-847-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-847-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-847-058dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-847-05e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-847-059bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-847-05110d247fa046…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
A088771-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16

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 UTC2026-02A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-163f01610625f2…
2019-09-15 20:21 UTC2019-09A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088771-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTIC1985-01-16cb3db0bc1861…

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
21695-847-052019-09-24C16284748780-1934fe258-49a1-48b1-e053-8cdaa90a720aDexamethasone Sodium Phosphate Ophthalmic Solution, USP Equivalent to dexamethasone phosphate 0.1% STERILE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-847-05Dexamethasone Sodium Phosphate5 mL in 1 BOTTLE, PLASTICSOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-847-05ML - Milliliter21695-847ed2323f1-b242-49dc-a6ca-ea861546562c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dexamethasone sodium phosphateACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
dexamethasoneACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74DEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-847DEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101220_a2c2385e-74a8-4a18-92ec-be8a1380e13a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226343dexAMETHasone sodium phosphate 0.1 % Ophthalmic SolutionPSNa2c2385e-74a8-4a18-92ec-be8a1380e13a1
226343dexamethasone phosphate 1 MG/ML Ophthalmic SolutionSCDa2c2385e-74a8-4a18-92ec-be8a1380e13a1
226343dexamethasone sodium phosphate 0.1 % Ophthalmic SolutionSYa2c2385e-74a8-4a18-92ec-be8a1380e13a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-847-05216950847055 mL in 1 BOTTLE, PLASTIC5 mlHistorical