FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
55154-9364
11-digit product format
551549364
Labeler code
55154
Product ID
55154-9364_f9fd6923-25de-4376-a81d-a836bbe947c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE SODIUM PHOSPHATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA084916
Marketing category
ANDA
Marketing start
2000-09-07
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

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 Identifiers#

Field, Values table
FieldValues
UniiAI9376Y64P
Rxcui1116927

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
55154-9364-5Dexamethasone Sodium Phosphate5 in 1 BAGINJECTION, SOLUTION512
55154-9364-5Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-9364-5ML - Milliliter55154-936402e1c68f-2218-46b7-90da-62c74114730912017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9364DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 2 package rows20241225_6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN6d3cbd54-93ef-40fe-b15a-7a4f52dc5f7112
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD6d3cbd54-93ef-40fe-b15a-7a4f52dc5f7112
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY6d3cbd54-93ef-40fe-b15a-7a4f52dc5f7112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-9364-5551549364055 VIAL in 1 BAG (55154-9364-5) / 1 mL in 1 VIAL5 vial2000-09-070000-00-00NoNoCurrent