FDA.reportPublic FDA data

Dexamethasone

Product NDC
68788-8467
11-digit product format
687888467
Labeler code
68788
Product ID
68788-8467_d8f358ac-c667-4a0a-b2d9-e8146c7e26a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA215604
Marketing category
ANDA
Marketing start
2023-06-26
Substance
DEXAMETHASONE
Active strength
4 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
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
68788-8467-1Dexamethasone12 in 1 BOTTLETABLET124
68788-8467-3Dexamethasone30 in 1 BOTTLETABLET304
68788-8467-5Dexamethasone15 in 1 BOTTLETABLET154
68788-8467-6Dexamethasone6 in 1 BOTTLETABLET64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8467-1EA - Each68788-8467407ecb00-1247-4eee-a856-a916ff195ce612023-08-08
68788-8467-3EA - Each68788-8467001c5d8c-4621-47c7-b9da-f5f2c2fe4dfd12023-08-08
68788-8467-5EA - Each68788-8467cb6b55bd-8ce0-4e1d-b9bb-b60865b9f22712023-08-08
68788-8467-6EA - Each68788-8467189ea87f-db98-4bfa-95cf-34020d199bd412023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8467DEXAMETHASONE TABLET [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, 4 package rows20250316_c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSNc4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd4
197582dexamethasone 4 MG Oral TabletSCDc4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8467-16878884670112 TABLET in 1 BOTTLE (68788-8467-1) 12 tablet2023-06-26NoNoHistorical
68788-8467-36878884670330 TABLET in 1 BOTTLE (68788-8467-3) 30 tablet2023-06-26NoNoHistorical
68788-8467-56878884670515 TABLET in 1 BOTTLE (68788-8467-5) 15 tablet2023-06-26NoNoHistorical
68788-8467-6687888467066 TABLET in 1 BOTTLE (68788-8467-6) 6 tablet2023-06-26NoNoHistorical