Dexamethasone

Product NDC
54879-003
11-digit product format
548790003
Labeler code
54879
Product ID
54879-003_edabb5da-f601-8bc5-e053-2a95a90a1249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
ELIXIR
Route
ORAL
Labeler
STI Pharma LLC
Application
ANDA084754
Marketing category
ANDA
Marketing start
1976-09-21
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
1 mg/5mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54879-003-082025-04-21C16284748780-11030e365-09af-111a-e063-dadaa90a10e2320747b3-5cf1-4e0c-b670-c6a9e72a8845
54879-003-082024-01-30C16284748780-11030e365-09af-111a-e063-dadaa90a10e2320747b3-5cf1-4e0c-b670-c6a9e72a8845

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54879-003-08ML - Milliliter54879-003fba2ee89-81c4-4a73-84d1-65c5dd3c14c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DexamethasoneACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
AlcoholINACTIVE INGREDIENT3K9958V90MDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Edetate SodiumINACTIVE INGREDIENTMP1J8420LUDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DEXAMETHASONE ELIXIR [STI PHARMA LLC]3
RaspberryINACTIVE INGREDIENT4N14V5R27WDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
SorbitolINACTIVE INGREDIENT506T60A25RDEXAMETHASONE ELIXIR [STI PHARMA LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE ELIXIR [STI PHARMA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54879-003DEXAMETHASONE ELIXIR [STI PHARMA LLC]9Legacy NDC20250425_320747b3-5cf1-4e0c-b670-c6a9e72a8845.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309686dexAMETHasone 0.5 MG in 5 mL Oral SolutionPSN4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 0.1 MG/ML Oral SolutionSCD4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 0.5 MG per 5 ML Oral SolutionSY4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 1 MG per 10 ML Oral SolutionSY4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54879-003-0854879000308237 mL in 1 BOTTLE, GLASS (54879-003-08) 237 ml1976-09-210000-00-00NoNoCurrent