Dexamethasone Sodium Phosphate

Product NDC
24208-720
11-digit product format
242080720
Labeler code
24208
Product ID
24208-720_466190ae-63f8-4b89-a71e-f1b91f90c764
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA040069
Marketing category
ANDA
Marketing start
1996-07-26
Substance
DEXAMETHASONE SODIUM PHOSPHATE
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-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…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone Sodium Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE SODIUM PHOSPHATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AI9376Y64PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
226343Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6bdcefbe-51e3-4ca4-afda-5aeca7b6fa73Available on FDA.report

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
24208-720-02Dexamethasone Sodium Phosphate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS58
24208-720-02Dexamethasone Sodium Phosphate1 in 1 CARTONSOLUTION/ DROPS18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-720-02ML - Milliliter24208-7209ed538de-4fde-422a-807f-51e6bec1c7aa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
CREATININEINACTIVE INGREDIENTAYI8EX34EUDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6IDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QODEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
WATERINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
Dexamethasone Sodium PhosphateACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [STAT RX USA]1
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [STAT RX USA]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
CREATININEINACTIVE INGREDIENTAYI8EX34EUDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6IDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QODEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-720DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]8Current NDC, Legacy NDC, 2 package rows20221005_6bdcefbe-51e3-4ca4-afda-5aeca7b6fa73.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
ndc (product): 24208-720

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226343dexAMETHasone sodium phosphate 0.1 % Ophthalmic SolutionPSN6bdcefbe-51e3-4ca4-afda-5aeca7b6fa738
226343dexamethasone phosphate 1 MG/ML Ophthalmic SolutionSCD6bdcefbe-51e3-4ca4-afda-5aeca7b6fa738
226343dexamethasone sodium phosphate 0.1 % Ophthalmic SolutionSY6bdcefbe-51e3-4ca4-afda-5aeca7b6fa738
226343dexAMETHasone sodium phosphate 0.1 % Ophthalmic SolutionPSNb61aec30-66c0-4abe-a8ad-2d98d88f21b81
226343dexAMETHasone sodium phosphate 0.1 % Ophthalmic SolutionPSNd3ac05f5-3c52-43a0-99a0-2a0c0f3097691
226343dexamethasone phosphate 1 MG/ML Ophthalmic SolutionSCDb61aec30-66c0-4abe-a8ad-2d98d88f21b81
226343dexamethasone phosphate 1 MG/ML Ophthalmic SolutionSCDd3ac05f5-3c52-43a0-99a0-2a0c0f3097691
226343dexamethasone sodium phosphate 0.1 % Ophthalmic SolutionSYb61aec30-66c0-4abe-a8ad-2d98d88f21b81
226343dexamethasone sodium phosphate 0.1 % Ophthalmic SolutionSYd3ac05f5-3c52-43a0-99a0-2a0c0f3097691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-720-02242080720021 BOTTLE, DROPPER in 1 CARTON (24208-720-02) / 5 mL in 1 BOTTLE, DROPPER1996-07-260000-00-00NoNoCurrent