FDA.reportPublic FDA data

Dexamethasone

Product NDC
71335-3054
11-digit product format
713353054
Labeler code
71335
Product ID
71335-3054_015805cd-1e17-4e86-9a37-668597065f48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216282
Marketing category
ANDA
Marketing start
2024-04-15
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
71335-3054-0Dexamethasone4 in 1 BOTTLETABLET41
71335-3054-1Dexamethasone30 in 1 BOTTLETABLET301
71335-3054-2Dexamethasone6 in 1 BOTTLETABLET61
71335-3054-3Dexamethasone3 in 1 BOTTLETABLET31
71335-3054-4Dexamethasone15 in 1 BOTTLETABLET151
71335-3054-5Dexamethasone40 in 1 BOTTLETABLET401
71335-3054-6Dexamethasone60 in 1 BOTTLETABLET601
71335-3054-7Dexamethasone28 in 1 BOTTLETABLET281
71335-3054-8Dexamethasone90 in 1 BOTTLETABLET901
71335-3054-9Dexamethasone10 in 1 BOTTLETABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSNe830be9d-0a8c-4712-93c6-284c208d6f0d1
197582dexamethasone 4 MG Oral TabletSCDe830be9d-0a8c-4712-93c6-284c208d6f0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3054-0713353054004 TABLET in 1 BOTTLE (71335-3054-0) 4 tablet2026-02-05NoNoHistorical
71335-3054-17133530540130 TABLET in 1 BOTTLE (71335-3054-1) 30 tablet2026-02-05NoNoHistorical
71335-3054-2713353054026 TABLET in 1 BOTTLE (71335-3054-2) 6 tablet2026-02-05NoNoHistorical
71335-3054-3713353054033 TABLET in 1 BOTTLE (71335-3054-3) 3 tablet2026-02-05NoNoHistorical
71335-3054-47133530540415 TABLET in 1 BOTTLE (71335-3054-4) 15 tablet2026-02-05NoNoHistorical
71335-3054-57133530540540 TABLET in 1 BOTTLE (71335-3054-5) 40 tablet2026-02-05NoNoHistorical
71335-3054-67133530540660 TABLET in 1 BOTTLE (71335-3054-6) 60 tablet2026-02-05NoNoHistorical
71335-3054-77133530540728 TABLET in 1 BOTTLE (71335-3054-7) 28 tablet2026-02-05NoNoHistorical
71335-3054-87133530540890 TABLET in 1 BOTTLE (71335-3054-8) 90 tablet2026-02-05NoNoHistorical
71335-3054-97133530540910 TABLET in 1 BOTTLE (71335-3054-9) 10 tablet2026-02-05NoNoHistorical