FDA.reportPublic FDA data

DEXAMETHASONE

Product NDC
61919-827
11-digit product format
619190827
Labeler code
61919
Product ID
61919-827_0e883a0f-ef16-109e-e063-6294a90aa908
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA084610
Marketing category
ANDA
Marketing start
2020-06-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-827-152025-01-30C16284748780-11030e365-4de8-111a-e063-dadaa90a10e2Dexamethasone
61919-827-212025-01-30C16284748780-11030e365-4de8-111a-e063-dadaa90a10e2Dexamethasone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-827-15DEXAMETHASONE15 in 1 BOTTLETABLET158
61919-827-21DEXAMETHASONE21 in 1 BOTTLETABLET218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-827-15EA - Each61919-827f17dbc57-64ab-4ad7-b506-96d30b9fa68c12020-07-13
61919-827-21EA - Each61919-82720993cf8-7660-4f5b-8a1b-f8e6e7c9943212020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-827DEXAMETHASONE TABLET DEXAMETHASONE TABLET [DIRECT RX]7Current NDC, Legacy NDC, 2 package rows20200618_3ff06262-4c6f-4423-99fa-b4d8191ea133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197580dexAMETHasone 1.5 MG Oral TabletPSN3ff06262-4c6f-4423-99fa-b4d8191ea1338
197580dexamethasone 1.5 MG Oral TabletSCD3ff06262-4c6f-4423-99fa-b4d8191ea1338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-827-156191908271515 TABLET in 1 BOTTLE (61919-827-15) 15 tablet2020-06-150000-00-00NoNoCurrent
61919-827-216191908272121 TABLET in 1 BOTTLE (61919-827-21) 21 tablet2020-06-150000-00-00NoNoCurrent