Dexamethasone Sodium Phosphate

Product NDC
52584-421
Requested package NDC
52584-421-00
11-digit product format
525840421
Labeler code
52584
Product ID
52584-421_4c1a6269-b693-454e-8554-e8fad49e2444
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
General Injectables and Vaccines, Inc
Application
ANDA040803
Marketing category
ANDA
Marketing start
2015-08-21
Marketing end
2022-06-30
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
4 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52584-42152584-421-00DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A040803-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040803-001AP

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 UTC2026-02A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293f01610625f2…
2019-09-15 20:21 UTC2019-09A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040803-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040803-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040803-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040803-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040803-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040803-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040803-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040803-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040803-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040803-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040803-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040803-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040803-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040803-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040803-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040803-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040803-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040803-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040803-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040803-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040803-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040803-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040803-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040803-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040803-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040803-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040803-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040803-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040803-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040803-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040803-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040803-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040803-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040803-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040803-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040803-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040803-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040803-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040803-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040803-001AP1cb3db0bc1861…

DailyMed Socrata Ingredients#

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLCa8aee11f-c928-41ef-8df8-e6d8b355536c2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHenry Schein, Inc.c464ffde-f64e-4716-92d2-720a107932482026-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution384206f5-75ed-9bd2-e063-6294a90a50382025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution42c879cc-38dc-c9bc-e063-6294a90a204d2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.36854dbc-22f2-5df9-e063-6394a90ad9342025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication Solutionsd21f3055-8a8a-4797-93e2-c8f582cbdae12024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLCdff598e8-e662-411f-978d-4ba3fb8ef7db2024-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC86091483-2053-5da8-e053-2a91aa0a6f452023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC81a28bdb-b186-8047-e053-2a91aa0a4e0a2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC81a0503c-39fe-1c67-e053-2a91aa0a5b8f2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.b2ce414a-3b1f-4533-bb3a-18594529dead2020-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLC836f8017-d023-410b-8515-ec776e73ca592019-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040803
application number: ANDA040803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-421-00525840421001 VIAL, MULTI-DOSE in 1 BAG (52584-421-00) > 30 mL in 1 VIAL, MULTI-DOSE2015-08-212022-06-30NoNoCurrent