DEXAMETHASONE

Product NDC
72789-534
11-digit product format
727890534
Labeler code
72789
Product ID
72789-534_4589a128-79eb-aa64-e063-6294a90a953b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA218372
Marketing category
ANDA
Marketing start
2025-11-21
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
72789-534-01DEXAMETHASONE100 in 1 BOTTLE, PLASTICTABLET1004
72789-534-28DEXAMETHASONE28 in 1 BOTTLE, PLASTICTABLET284
72789-534-95DEXAMETHASONE1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-534-01EA - Each72789-5344cf879ef-3d0d-496f-8da1-50462a85e91312026-01-08
72789-534-28EA - Each72789-5349430f0c6-0689-4318-9398-241570f15e7212026-01-08
72789-534-95EA - Each72789-534cc65d7af-6037-4cb4-9e83-89c6153411b412026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSNa8d6792e-757e-4dc6-adf5-0d92110754284
197582dexamethasone 4 MG Oral TabletSCDa8d6792e-757e-4dc6-adf5-0d92110754284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-534-0172789053401100 TABLET in 1 BOTTLE, PLASTIC (72789-534-01) 100 tablet2025-11-21NoNoHistorical
72789-534-287278905342828 TABLET in 1 BOTTLE, PLASTIC (72789-534-28) 28 tablet2025-12-09NoNoHistorical
72789-534-95727890534951000 TABLET in 1 BOTTLE, PLASTIC (72789-534-95) 1000 tablet2025-11-21NoNoHistorical