FDA.reportPublic FDA data

Dexamethasone

Product NDC
80425-0346
11-digit product format
804250346
Labeler code
80425
Product ID
80425-0346_4250a0b0-e539-57c9-e063-6294a90a4b55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA201270
Marketing category
ANDA
Marketing start
2023-07-31
Substance
DEXAMETHASONE
Active strength
1.5 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
DEXAMETHASONE1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197580

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
80425-0346-1Dexamethasone21 in 1 BOTTLETABLET213
80425-0346-2Dexamethasone27 in 1 BOTTLETABLET273
80425-0346-3Dexamethasone49 in 1 BOTTLETABLET493
80425-0346-4Dexamethasone60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0346-1EA - Each80425-0346cc30e2dc-1d7e-4d05-9c79-650d6a01ee1912023-09-05
80425-0346-2EA - Each80425-0346f4c3be7a-7231-40e4-8035-445481a639a312023-09-05
80425-0346-3EA - Each80425-0346a2a91936-6977-48be-9b70-53832fb4db6c12023-09-05
80425-0346-4EA - Each80425-0346f76dfd8e-4c38-42e6-91ce-374d4f4a733b12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0346DEXAMETHASONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20250102_01cfaa3e-5e30-18fa-e063-6394a90a084e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197580dexAMETHasone 1.5 MG Oral TabletPSN01cfaa3e-5e30-18fa-e063-6394a90a084e3
197580dexamethasone 1.5 MG Oral TabletSCD01cfaa3e-5e30-18fa-e063-6394a90a084e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0346-18042503460121 TABLET in 1 BOTTLE (80425-0346-1) 21 tablet2023-07-31NoNoHistorical
80425-0346-28042503460227 TABLET in 1 BOTTLE (80425-0346-2) 27 tablet2023-07-31NoNoHistorical
80425-0346-38042503460349 TABLET in 1 BOTTLE (80425-0346-3) 49 tablet2023-07-31NoNoHistorical
80425-0346-48042503460460 TABLET in 1 BOTTLE (80425-0346-4) 60 tablet2025-10-28NoNoHistorical