Dexamethasone Sodium Phosphate

Product NDC
0404-9842
11-digit product format
004049842
Labeler code
0404
Product ID
0404-9842_35e2db12-e807-4a98-a23c-a76c7e4fb296
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA040802
Marketing category
ANDA
Marketing start
2022-01-09
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
10 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
A040802-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 10MG 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
A040802-001AP

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 UTC2026-02A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293f01610625f2…
2019-09-15 20:21 UTC2019-09A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040802-001DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG 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 UTC2026-02A040802-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040802-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040802-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040802-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040802-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040802-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040802-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040802-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040802-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040802-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040802-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040802-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040802-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040802-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040802-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040802-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040802-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040802-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040802-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040802-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040802-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040802-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040802-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040802-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040802-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040802-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040802-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040802-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040802-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040802-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040802-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040802-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040802-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040802-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040802-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040802-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040802-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040802-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040802-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040802-001AP1cb3db0bc1861…

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 PHOSPHATE10 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
309696Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ded4eac-3f86-4cf8-a05f-3e9c52984d6cAvailable 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
0404-9842-10Dexamethasone Sodium Phosphate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION106
0404-9842-10Dexamethasone Sodium Phosphate1 in 1 BAGINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9842DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20250205_6ded4eac-3f86-4cf8-a05f-3e9c52984d6c.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 · 6 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): 040802
application number: ANDA040802
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHenry Schein, Inc.6ded4eac-3f86-4cf8-a05f-3e9c52984d6c2026-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040802
application number: ANDA040802
ndc (product): 0404-9842
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.36854dbc-22f2-5df9-e063-6394a90ad9342025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040802
application number: ANDA040802
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLCdff598e8-e662-411f-978d-4ba3fb8ef7db2024-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040802
application number: ANDA040802
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC69339a97-99dd-7297-e053-2991aa0a7fb82023-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040802
application number: ANDA040802
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLC836f8017-d023-410b-8515-ec776e73ca592019-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040802
application number: ANDA040802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN6ded4eac-3f86-4cf8-a05f-3e9c52984d6c6
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCD6ded4eac-3f86-4cf8-a05f-3e9c52984d6c6
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSY6ded4eac-3f86-4cf8-a05f-3e9c52984d6c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9842-10004049842101 VIAL, MULTI-DOSE in 1 BAG (0404-9842-10) / 10 mL in 1 VIAL, MULTI-DOSE2022-01-090000-00-00NoNoCurrent