FDA.reportPublic FDA data

Dexamethasone

Product NDC
55289-582
11-digit product format
552890582
Labeler code
55289
Product ID
55289-582_2ac01b74-f082-65ff-e063-6394a90aa606
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA084612
Marketing category
ANDA
Marketing start
1978-07-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-582-04Dexamethasone4 in 1 BOTTLE, PLASTICTABLET425
55289-582-06Dexamethasone6 in 1 BOTTLE, PLASTICTABLET625
55289-582-10Dexamethasone10 in 1 BOTTLE, PLASTICTABLET1025
55289-582-15Dexamethasone15 in 1 BOTTLE, PLASTICTABLET1525
55289-582-21Dexamethasone21 in 1 BOTTLE, PLASTICTABLET2125
55289-582-28Dexamethasone28 in 1 BOTTLE, PLASTICTABLET2825

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-582DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 6 package rows20250104_89e1d458-7caa-430f-9c54-360889899a73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSN89e1d458-7caa-430f-9c54-360889899a7325
197582dexamethasone 4 MG Oral TabletSCD89e1d458-7caa-430f-9c54-360889899a7325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-582-04552890582044 TABLET in 1 BOTTLE, PLASTIC (55289-582-04) 4 tablet2013-10-210000-00-00NoNoCurrent
55289-582-06552890582066 TABLET in 1 BOTTLE, PLASTIC (55289-582-06) 6 tablet2013-10-210000-00-00NoNoCurrent
55289-582-105528905821010 TABLET in 1 BOTTLE, PLASTIC (55289-582-10) 10 tablet2013-10-210000-00-00NoNoCurrent
55289-582-155528905821515 TABLET in 1 BOTTLE, PLASTIC (55289-582-15) 15 tablet2013-10-250000-00-00NoNoCurrent
55289-582-215528905822121 TABLET in 1 BOTTLE, PLASTIC (55289-582-21) 21 tablet2013-10-210000-00-00NoNoCurrent
55289-582-285528905822828 TABLET in 1 BOTTLE, PLASTIC (55289-582-28) 28 tablet2013-10-210000-00-00NoNoCurrent