DEXAMETHASONE SODIUM PHOSPHATE

Product NDC
50090-3300
11-digit product format
500903300
Labeler code
50090
Product ID
50090-3300_f2187a01-5e06-4127-992e-9e88d780803d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE SODIUM PHOSPHATE
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
A-S Medication Solutions
Application
ANDA206781
Marketing category
ANDA
Marketing start
2015-12-01
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
4 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A206781-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION2015-12-01

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 UTC2026-02A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION2015-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION2015-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION2015-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-013f01610625f2…
2019-09-15 20:21 UTC2019-09A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206781-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2015-12-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206781-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206781-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206781-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206781-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206781-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206781-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206781-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206781-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206781-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206781-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206781-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206781-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206781-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206781-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206781-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206781-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206781-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206781-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A206781-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206781-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206781-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206781-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A206781-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206781-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206781-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206781-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206781-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206781-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206781-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206781-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206781-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206781-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206781-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206781-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206781-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206781-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206781-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
DEXAMETHASONE SODIUM PHOSPHATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE SODIUM PHOSPHATE4 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
1116927Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe464a39-7820-435c-9385-a4a96d8a38c8Available 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
50090-3300-0DEXAMETHASONE SODIUM PHOSPHATE30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3014
50090-3300-0DEXAMETHASONE SODIUM PHOSPHATE25 in 1 CARTONINJECTION, SOLUTION2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3300-0ML - Milliliter50090-33000abe4b18-e424-487d-9303-905c7aea120112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3300DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20231213_fe464a39-7820-435c-9385-a4a96d8a38c8.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEA-S Medication Solutionsfe464a39-7820-435c-9385-a4a96d8a38c82026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206781
application number: ANDA206781
ndc (product): 50090-3300
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEugia US LLCce7ad5a4-a9c5-42d6-87cc-ca16556208d22025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206781
application number: ANDA206781
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst9a426a16-19f8-567e-e053-2a95a90a0a5b2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206781
application number: ANDA206781
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC69346605-dff6-1958-e053-2a91aa0a0e1a2023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206781
application number: ANDA206781
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC69485218-9330-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206781
application number: ANDA206781
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC667323ea-5a5e-3465-e053-2a91aa0a16672023-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206781
application number: ANDA206781
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.ca762fbf-6bf5-4b39-8f40-3fb5f1f777782022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206781
application number: ANDA206781

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNfe464a39-7820-435c-9385-a4a96d8a38c814
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDfe464a39-7820-435c-9385-a4a96d8a38c814
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYfe464a39-7820-435c-9385-a4a96d8a38c814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3300-05009033000025 VIAL, MULTI-DOSE in 1 CARTON (50090-3300-0) / 30 mL in 1 VIAL, MULTI-DOSE2017-12-070000-00-00NoNoCurrent