FDA.reportPublic FDA data

Dexamethasone

Product NDC
0054-8176
11-digit product format
000548176
Labeler code
0054
Product ID
0054-8176_286734bc-8329-4f44-a20b-610cf7b67591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA, Inc.
Application
ANDA084612
Marketing category
ANDA
Marketing start
1982-08-26
Substance
DEXAMETHASONE
Active strength
2 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
DEXAMETHASONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197577, 197579, 197580, 197581, 197582, 197583, 309684, 309686, 343033

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-8176-25Dexamethasone1 in 1 BLISTER PACKTABLET111
0054-8176-25Dexamethasone100 in 1 CARTONTABLET10011
0054-4183-25Dexamethasone100 in 1 BOTTLE, PLASTICTABLET1008
0054-8176-25Dexamethasone10 in 1 CARTONTABLET108
0054-8176-25Dexamethasone10 in 1 BLISTER PACKTABLET108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-8176DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [HIKMA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 2 package rows20240308_b15200fb-1826-472b-a907-e677a272513b.zip
0054-8176DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION [ROXANE LABORATORIES, INC.]8Current NDC, Legacy NDC, 3 package rows20071101_537B424A-3E07-4C81-978C-1AD99014032A.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197581dexAMETHasone 2 MG Oral TabletPSNbf8acfdb-8dc8-4a69-90b0-33c680c421d615
197582dexAMETHasone 4 MG Oral TabletPSNbf8acfdb-8dc8-4a69-90b0-33c680c421d615
197581dexamethasone 2 MG Oral TabletSCDbf8acfdb-8dc8-4a69-90b0-33c680c421d615
197582dexamethasone 4 MG Oral TabletSCDbf8acfdb-8dc8-4a69-90b0-33c680c421d615
309686dexAMETHasone 0.5 MG in 5 mL Oral SolutionPSNb15200fb-1826-472b-a907-e677a272513b11
197577dexAMETHasone 0.5 MG Oral TabletPSNb15200fb-1826-472b-a907-e677a272513b11
343033dexAMETHasone 0.75 MG Oral TabletPSNb15200fb-1826-472b-a907-e677a272513b11
309684dexAMETHasone 1 MG in 1 mL Concentrate for Oral SolutionPSNb15200fb-1826-472b-a907-e677a272513b11
197579dexAMETHasone 1 MG Oral TabletPSNb15200fb-1826-472b-a907-e677a272513b11
197580dexAMETHasone 1.5 MG Oral TabletPSNb15200fb-1826-472b-a907-e677a272513b11
197581dexAMETHasone 2 MG Oral TabletPSNb15200fb-1826-472b-a907-e677a272513b11
197582dexAMETHasone 4 MG Oral TabletPSNb15200fb-1826-472b-a907-e677a272513b11
197583dexAMETHasone 6 MG Oral TabletPSNb15200fb-1826-472b-a907-e677a272513b11
309686dexamethasone 0.1 MG/ML Oral SolutionSCDb15200fb-1826-472b-a907-e677a272513b11
197577dexamethasone 0.5 MG Oral TabletSCDb15200fb-1826-472b-a907-e677a272513b11
343033dexamethasone 0.75 MG Oral TabletSCDb15200fb-1826-472b-a907-e677a272513b11
197579dexamethasone 1 MG Oral TabletSCDb15200fb-1826-472b-a907-e677a272513b11
309684dexamethasone 1 MG/ML Oral SolutionSCDb15200fb-1826-472b-a907-e677a272513b11
197580dexamethasone 1.5 MG Oral TabletSCDb15200fb-1826-472b-a907-e677a272513b11
197581dexamethasone 2 MG Oral TabletSCDb15200fb-1826-472b-a907-e677a272513b11
197582dexamethasone 4 MG Oral TabletSCDb15200fb-1826-472b-a907-e677a272513b11
197583dexamethasone 6 MG Oral TabletSCDb15200fb-1826-472b-a907-e677a272513b11
309686dexamethasone 0.5 MG per 5 ML Oral SolutionSYb15200fb-1826-472b-a907-e677a272513b11
309684dexamethasone 1 MG per 1 ML Concentrate for Oral SolutionSYb15200fb-1826-472b-a907-e677a272513b11
309686dexamethasone 1 MG per 10 ML Oral SolutionSYb15200fb-1826-472b-a907-e677a272513b11
309686dexAMETHasone 0.5 MG in 5 mL Oral SolutionPSN537b424a-3e07-4c81-978c-1ad99014032a8
197577dexAMETHasone 0.5 MG Oral TabletPSN537b424a-3e07-4c81-978c-1ad99014032a8
343033dexAMETHasone 0.75 MG Oral TabletPSN537b424a-3e07-4c81-978c-1ad99014032a8
309684dexAMETHasone 1 MG in 1 mL Concentrate for Oral SolutionPSN537b424a-3e07-4c81-978c-1ad99014032a8
197579dexAMETHasone 1 MG Oral TabletPSN537b424a-3e07-4c81-978c-1ad99014032a8
197580dexAMETHasone 1.5 MG Oral TabletPSN537b424a-3e07-4c81-978c-1ad99014032a8
197581dexAMETHasone 2 MG Oral TabletPSN537b424a-3e07-4c81-978c-1ad99014032a8
197582dexAMETHasone 4 MG Oral TabletPSN537b424a-3e07-4c81-978c-1ad99014032a8
197583dexAMETHasone 6 MG Oral TabletPSN537b424a-3e07-4c81-978c-1ad99014032a8
309686dexamethasone 0.1 MG/ML Oral SolutionSCD537b424a-3e07-4c81-978c-1ad99014032a8
197577dexamethasone 0.5 MG Oral TabletSCD537b424a-3e07-4c81-978c-1ad99014032a8
343033dexamethasone 0.75 MG Oral TabletSCD537b424a-3e07-4c81-978c-1ad99014032a8
197579dexamethasone 1 MG Oral TabletSCD537b424a-3e07-4c81-978c-1ad99014032a8
309684dexamethasone 1 MG/ML Oral SolutionSCD537b424a-3e07-4c81-978c-1ad99014032a8
197580dexamethasone 1.5 MG Oral TabletSCD537b424a-3e07-4c81-978c-1ad99014032a8
197581dexamethasone 2 MG Oral TabletSCD537b424a-3e07-4c81-978c-1ad99014032a8
197582dexamethasone 4 MG Oral TabletSCD537b424a-3e07-4c81-978c-1ad99014032a8
197583dexamethasone 6 MG Oral TabletSCD537b424a-3e07-4c81-978c-1ad99014032a8
309686dexamethasone 0.5 MG per 5 ML Oral SolutionSY537b424a-3e07-4c81-978c-1ad99014032a8
309684dexamethasone 1 MG per 1 ML Concentrate for Oral SolutionSY537b424a-3e07-4c81-978c-1ad99014032a8
309686dexamethasone 1 MG per 10 ML Oral SolutionSY537b424a-3e07-4c81-978c-1ad99014032a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4183-2500054418325100 in 1 BOTTLE, PLASTICHistorical
0054-8176-2500054817625100 BLISTER PACK in 1 CARTON (0054-8176-25) / 1 TABLET in 1 BLISTER PACK100 blister pack1982-08-260000-00-00NoNoCurrent