FDA.reportPublic FDA data

Dexamethasone

Product NDC
0054-4180
11-digit product format
000544180
Labeler code
0054
Product ID
0054-4180_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
1975-06-03
Substance
DEXAMETHASONE
Active strength
.75 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
DEXAMETHASONE.75 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
0054-4180-25Dexamethasone100 in 1 BOTTLE, PLASTICTABLET10011
0054-4180-25Dexamethasone100 in 1 BOTTLE, PLASTICTABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4180DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [HIKMA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 1 package rows20240308_b15200fb-1826-472b-a907-e677a272513b.zip
0054-4180DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION [ROXANE LABORATORIES, INC.]8Current NDC, Legacy NDC20071101_537B424A-3E07-4C81-978C-1AD99014032A.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
343033dexAMETHasone 0.75 MG Oral TabletPSNa9fd2013-0797-4ec4-82c5-07d2825226251020
197579dexAMETHasone 1 MG Oral TabletPSNa9fd2013-0797-4ec4-82c5-07d2825226251020
197583dexAMETHasone 6 MG Oral TabletPSNa9fd2013-0797-4ec4-82c5-07d2825226251020
343033dexamethasone 0.75 MG Oral TabletSCDa9fd2013-0797-4ec4-82c5-07d2825226251020
197579dexamethasone 1 MG Oral TabletSCDa9fd2013-0797-4ec4-82c5-07d2825226251020
197583dexamethasone 6 MG Oral TabletSCDa9fd2013-0797-4ec4-82c5-07d2825226251020
343033dexAMETHasone 0.75 MG Oral TabletPSN736861fa-1df8-4afd-ba4a-dd7d7bffd86518
343033dexamethasone 0.75 MG Oral TabletSCD736861fa-1df8-4afd-ba4a-dd7d7bffd86518
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
343033dexAMETHasone 0.75 MG Oral TabletPSN955db121-79f4-47eb-8c10-01b2d8b411e47
343033dexamethasone 0.75 MG Oral TabletSCD955db121-79f4-47eb-8c10-01b2d8b411e47
343033dexAMETHasone 0.75 MG Oral TabletPSNe90cb7f5-5e99-fbf3-e053-2995a90a70aa2
343033dexamethasone 0.75 MG Oral TabletSCDe90cb7f5-5e99-fbf3-e053-2995a90a70aa2
197577dexAMETHasone 0.5 MG Oral TabletPSNe5c28db5-efce-49a7-9e5f-12338d1f216b1
343033dexAMETHasone 0.75 MG Oral TabletPSN0372f916-0a26-4115-8075-2d575bfbc15e1
343033dexAMETHasone 0.75 MG Oral TabletPSN55d94620-bb62-4f78-9dc5-cb705b79020f1
343033dexAMETHasone 0.75 MG Oral TabletPSNe5c28db5-efce-49a7-9e5f-12338d1f216b1
197580dexAMETHasone 1.5 MG Oral TabletPSNe5c28db5-efce-49a7-9e5f-12338d1f216b1
197581dexAMETHasone 2 MG Oral TabletPSNe5c28db5-efce-49a7-9e5f-12338d1f216b1
197582dexAMETHasone 4 MG Oral TabletPSNe5c28db5-efce-49a7-9e5f-12338d1f216b1
197583dexAMETHasone 6 MG Oral TabletPSNe5c28db5-efce-49a7-9e5f-12338d1f216b1
197577dexamethasone 0.5 MG Oral TabletSCDe5c28db5-efce-49a7-9e5f-12338d1f216b1
343033dexamethasone 0.75 MG Oral TabletSCDe5c28db5-efce-49a7-9e5f-12338d1f216b1
343033dexamethasone 0.75 MG Oral TabletSCD0372f916-0a26-4115-8075-2d575bfbc15e1
343033dexamethasone 0.75 MG Oral TabletSCD55d94620-bb62-4f78-9dc5-cb705b79020f1
197580dexamethasone 1.5 MG Oral TabletSCDe5c28db5-efce-49a7-9e5f-12338d1f216b1
197581dexamethasone 2 MG Oral TabletSCDe5c28db5-efce-49a7-9e5f-12338d1f216b1
197582dexamethasone 4 MG Oral TabletSCDe5c28db5-efce-49a7-9e5f-12338d1f216b1
197583dexamethasone 6 MG Oral TabletSCDe5c28db5-efce-49a7-9e5f-12338d1f216b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4180-2500054418025100 TABLET in 1 BOTTLE, PLASTIC (0054-4180-25) 100 tablet1975-06-030000-00-00NoNoCurrent