FDA.reportPublic FDA data

Dexamethasone

Product NDC
71335-3010
11-digit product format
713353010
Labeler code
71335
Product ID
71335-3010_320ac974-e60b-475f-afc7-9a52746e45c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217695
Marketing category
ANDA
Marketing start
2023-12-05
Substance
DEXAMETHASONE
Active strength
1.5 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
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
71335-3010-1Dexamethasone35 in 1 BOTTLETABLET351
71335-3010-2Dexamethasone21 in 1 BOTTLETABLET211
71335-3010-3Dexamethasone51 in 1 BOTTLETABLET511
71335-3010-4Dexamethasone90 in 1 BOTTLETABLET901
71335-3010-5Dexamethasone120 in 1 BOTTLETABLET1201
71335-3010-6Dexamethasone100 in 1 BOTTLETABLET1001
71335-3010-7Dexamethasone55 in 1 BOTTLETABLET551
71335-3010-8Dexamethasone10 in 1 BOTTLETABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197580dexAMETHasone 1.5 MG Oral TabletPSNb3217057-5945-452c-aa99-ab696fd8b5e71
197580dexamethasone 1.5 MG Oral TabletSCDb3217057-5945-452c-aa99-ab696fd8b5e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3010-17133530100135 TABLET in 1 BOTTLE (71335-3010-1) 35 tablet2026-02-04NoNoHistorical
71335-3010-27133530100221 TABLET in 1 BOTTLE (71335-3010-2) 21 tablet2026-02-04NoNoHistorical
71335-3010-37133530100351 TABLET in 1 BOTTLE (71335-3010-3) 51 tablet2026-02-04NoNoHistorical
71335-3010-47133530100490 TABLET in 1 BOTTLE (71335-3010-4) 90 tablet2026-02-04NoNoHistorical
71335-3010-571335301005120 TABLET in 1 BOTTLE (71335-3010-5) 120 tablet2026-02-04NoNoHistorical
71335-3010-671335301006100 TABLET in 1 BOTTLE (71335-3010-6) 100 tablet2026-02-04NoNoHistorical
71335-3010-77133530100755 TABLET in 1 BOTTLE (71335-3010-7) 55 tablet2026-02-04NoNoHistorical
71335-3010-87133530100810 TABLET in 1 BOTTLE (71335-3010-8) 10 tablet2026-02-04NoNoHistorical