FDA.reportPublic FDA data

Dexamethasone

Product NDC
85766-072
11-digit product format
857660072
Labeler code
85766
Product ID
85766-072_50316b9f-7ec6-f56e-e063-6294a90a6a75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA217695
Marketing category
ANDA
Marketing start
2023-11-01
Substance
DEXAMETHASONE
Active strength
2 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197581

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
85766-072-00Dexamethasone1000 in 1 BOTTLETABLET10002
85766-072-01Dexamethasone100 in 1 BOTTLETABLET1002
85766-072-07Dexamethasone7 in 1 BOTTLETABLET72
85766-072-14Dexamethasone14 in 1 BOTTLETABLET142
85766-072-20Dexamethasone20 in 1 BOTTLETABLET202
85766-072-30Dexamethasone30 in 1 BOTTLETABLET302
85766-072-60Dexamethasone60 in 1 BOTTLETABLET602
85766-072-90Dexamethasone90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197581dexAMETHasone 2 MG Oral TabletPSN12d19271-867b-41ae-a6d2-7e8de36370112
197581dexamethasone 2 MG Oral TabletSCD12d19271-867b-41ae-a6d2-7e8de36370112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-072-00857660072001000 TABLET in 1 BOTTLE (85766-072-00) 1000 tablet2025-10-08NoNoHistorical
85766-072-0185766007201100 TABLET in 1 BOTTLE (85766-072-01) 100 tablet2025-10-08NoNoHistorical
85766-072-07857660072077 TABLET in 1 BOTTLE (85766-072-07) 7 tablet2025-10-08NoNoHistorical
85766-072-148576600721414 TABLET in 1 BOTTLE (85766-072-14) 14 tablet2025-10-08NoNoHistorical
85766-072-208576600722020 TABLET in 1 BOTTLE (85766-072-20) 20 tablet2025-10-08NoNoHistorical
85766-072-308576600723030 TABLET in 1 BOTTLE (85766-072-30) 30 tablet2025-10-08NoNoHistorical
85766-072-608576600726060 TABLET in 1 BOTTLE (85766-072-60) 60 tablet2025-10-08NoNoHistorical
85766-072-908576600729090 TABLET in 1 BOTTLE (85766-072-90) 90 tablet2025-10-08NoNoHistorical