FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
84549-422
11-digit product format
845490422
Labeler code
84549
Product ID
84549-422_463e9fbd-e8ee-a852-e063-6394a90aa848
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
ProPharma Distribution
Application
ANDA040803
Marketing category
ANDA
Marketing start
2011-05-11
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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040803-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2008-08-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040803-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 84549-422
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

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
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
42c879cc-38dc-c9bc-e063-6294a90a204dAvailable 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
84549-422-54Dexamethasone Sodium Phosphate5 mL in 1 VIALINJECTION, SOLUTION52

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN42c879cc-38dc-c9bc-e063-6294a90a204d2
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD42c879cc-38dc-c9bc-e063-6294a90a204d2
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY42c879cc-38dc-c9bc-e063-6294a90a204d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-422-54845490422545 mL in 1 VIAL (84549-422-54) 5 ml2025-11-04NoNoCurrent