Dexamethasone Sodium Phosphate

Product NDC
76420-555
Requested package NDC
76420-555-01
11-digit product format
764200555
Labeler code
76420
Product ID
76420-555_f87f3d2b-033d-ea7a-e053-6394a90ac766
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
Asclemed USA, Inc.
Application
ANDA084282
Marketing category
ANDA
Marketing start
1975-07-15
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
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
A084282-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A084282-001AP

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 UTC2026-02A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084282-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAPApproved before 1982cb3db0bc1861…

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 UTC2026-02A084282-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084282-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084282-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084282-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084282-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084282-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084282-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084282-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084282-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084282-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084282-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084282-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084282-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084282-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084282-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084282-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084282-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084282-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084282-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084282-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084282-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A084282-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084282-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084282-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084282-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A084282-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084282-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084282-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084282-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084282-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084282-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084282-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084282-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084282-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084282-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084282-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084282-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084282-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084282-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084282-001AP1cb3db0bc1861…

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 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
1812194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d96d5e8-00bf-406b-b345-f1c31865fe94Available 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-555-01Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-555DEXAMETHASONE SODIUM PHOSPHATE INJECTION [ASCLEMED USA, INC.]1Current NDC, 1 package rows20230406_2d96d5e8-00bf-406b-b345-f1c31865fe94.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.1596a3b4-8c2c-41b4-b1eb-af09863eaa132026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHikma Pharmaceuticals USA Inc.0277cc0a-2fd4-4605-a310-b613be84ee262026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHenry Schein, Inc.d9b935d5-1b4f-4a08-8d40-57f397368fef2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECivica, Inc.d54a27f2-2af8-4f86-a7fd-453f6b1a99972024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst18a70010-6cc5-19e2-e063-6394a90a0ea62024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst8e36534f-d64c-7e7b-e053-2995a90ad48e2024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC8effed8e-9a75-eb3e-e053-2a95a90a965b2023-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC8969803e-2e45-1f28-e053-2995a90a05a72023-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.2d96d5e8-00bf-406b-b345-f1c31865fe942023-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084282
application number: ANDA084282
ndc (package): 76420-555-01
ndc (product): 76420-555
ndc11 (package): 76420055501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN2d96d5e8-00bf-406b-b345-f1c31865fe941
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD2d96d5e8-00bf-406b-b345-f1c31865fe941
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY2d96d5e8-00bf-406b-b345-f1c31865fe941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-555-01764200555011 mL in 1 VIAL (76420-555-01) 1 ml2023-04-04NoNoCurrent