FDA.reportPublic FDA data

Dexamethasone

Product NDC
68788-8824
11-digit product format
687888824
Labeler code
68788
Product ID
68788-8824_b883860c-27ba-4bac-8ae3-4cf4d82d5071
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217001
Marketing category
ANDA
Marketing start
2025-02-10
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
68788-8824-1Dexamethasone12 in 1 BOTTLETABLET121
68788-8824-3Dexamethasone30 in 1 BOTTLETABLET301
68788-8824-5Dexamethasone15 in 1 BOTTLETABLET151
68788-8824-6Dexamethasone6 in 1 BOTTLETABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8824-1EA - Each68788-8824e56cbac8-e146-4455-a1ee-1d9265c1dbeb12025-03-04
68788-8824-3EA - Each68788-8824b39d022f-2962-4035-90e1-4f58e77976d012025-03-04
68788-8824-5EA - Each68788-8824defa0764-46ca-425b-af46-6f83ba3ab7d912025-03-04
68788-8824-6EA - Each68788-882404296999-4c4f-45a7-8e00-fe204e68cc4f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8824DEXAMETHASONE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250212_b883860c-27ba-4bac-8ae3-4cf4d82d5071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSNb883860c-27ba-4bac-8ae3-4cf4d82d50711
197582dexamethasone 4 MG Oral TabletSCDb883860c-27ba-4bac-8ae3-4cf4d82d50711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8824-16878888240112 TABLET in 1 BOTTLE (68788-8824-1) 12 tablet2025-02-10NoNoCurrent
68788-8824-36878888240330 TABLET in 1 BOTTLE (68788-8824-3) 30 tablet2025-02-10NoNoCurrent
68788-8824-56878888240515 TABLET in 1 BOTTLE (68788-8824-5) 15 tablet2025-02-10NoNoCurrent
68788-8824-6687888824066 TABLET in 1 BOTTLE (68788-8824-6) 6 tablet2025-02-10NoNoCurrent