FDA.reportPublic FDA data

Dexamethasone

Product NDC
51655-012
11-digit product format
516550012
Labeler code
51655
Product ID
51655-012_46dda880-497d-fa44-e063-6394a90ad5f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA084612
Marketing category
ANDA
Marketing start
2014-08-11
Substance
DEXAMETHASONE
Active strength
4 mg/1
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197582

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-012-032024-07-24C16284748780-19d75b9d0-0214-f424-e053-dadaa90a57ceDexamethasone Tablets, USP
51655-012-872024-07-24C16284748780-19d75b9d0-0214-f424-e053-dadaa90a57ceDexamethasone Tablets, USP
51655-012-032020-01-31C16284748780-19d75b9d0-0214-f424-e053-dadaa90a57ceDexamethasone Tablets, USP
51655-012-872020-01-31C16284748780-19d75b9d0-0214-f424-e053-dadaa90a57ceDexamethasone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-012-03Dexamethasone3 in 1 BOTTLE, DISPENSINGTABLET35
51655-012-87Dexamethasone6 in 1 BOTTLE, DISPENSINGTABLET65

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHSONE (DEXAMETHASONE) TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHSONE (DEXAMETHASONE) TABLET [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-012DEXAMETHASONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240724_aa30086a-8551-413e-9cf2-6393093cfcfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSNaa30086a-8551-413e-9cf2-6393093cfcfd5
197582dexamethasone 4 MG Oral TabletSCDaa30086a-8551-413e-9cf2-6393093cfcfd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-012-03516550012033 TABLET in 1 BOTTLE, DISPENSING (51655-012-03) 3 tablet2014-08-11NoNoCurrent
51655-012-87516550012876 TABLET in 1 BOTTLE, DISPENSING (51655-012-87) 6 tablet2014-08-11NoNoCurrent