FDA.reportPublic FDA data

Dexamethasone

Product NDC
21695-382
11-digit product format
216950382
Labeler code
21695
Product ID
21695-382_77a91c9e-f445-4227-8369-c69837563bb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA084612
Marketing category
ANDA
Marketing start
1978-07-19
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-382-042019-09-24C16284748780-1934fe258-4cf8-48b1-e053-8cdaa90a720aDEXAMETHASONE Tablets USP,
21695-382-082019-09-24C16284748780-1934fe258-4cf8-48b1-e053-8cdaa90a720aDEXAMETHASONE Tablets USP,
21695-382-202019-09-24C16284748780-1934fe258-4cf8-48b1-e053-8cdaa90a720aDEXAMETHASONE Tablets USP,
21695-382-602019-09-24C16284748780-1934fe258-4cf8-48b1-e053-8cdaa90a720aDEXAMETHASONE Tablets USP,

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-382-04Dexamethasone4 in 1 BOTTLE, PLASTICTABLET42
21695-382-08Dexamethasone8 in 1 BOTTLE, PLASTICTABLET82
21695-382-20Dexamethasone20 in 1 BOTTLE, PLASTICTABLET202
21695-382-60Dexamethasone60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-382-04EA - Each21695-3825b76dc5b-7406-41d9-9548-3aa37bfb176f12012-07-24
21695-382-08EA - Each21695-382824958f5-21b2-4745-95a0-d4513612853a12012-07-24
21695-382-20EA - Each21695-3829965eeed-11c8-4e55-99cd-d9477e916ada12012-07-24
21695-382-60EA - Each21695-382e2b93ad4-ee63-4263-b06b-cfc3064dd91e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2
SUCROSEINACTIVE INGREDIENTC151H8M554DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-382DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 4 package rows20120511_7658e4b2-5b0d-487a-a603-8fd264cb02ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197579dexAMETHasone 1 MG Oral TabletPSN7658e4b2-5b0d-487a-a603-8fd264cb02ea2
197581dexAMETHasone 2 MG Oral TabletPSN7658e4b2-5b0d-487a-a603-8fd264cb02ea2
197582dexAMETHasone 4 MG Oral TabletPSN7658e4b2-5b0d-487a-a603-8fd264cb02ea2
197579dexamethasone 1 MG Oral TabletSCD7658e4b2-5b0d-487a-a603-8fd264cb02ea2
197581dexamethasone 2 MG Oral TabletSCD7658e4b2-5b0d-487a-a603-8fd264cb02ea2
197582dexamethasone 4 MG Oral TabletSCD7658e4b2-5b0d-487a-a603-8fd264cb02ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-382-04216950382044 in 1 BOTTLE, PLASTICHistorical
21695-382-08216950382088 in 1 BOTTLE, PLASTICHistorical
21695-382-202169503822020 in 1 BOTTLE, PLASTICHistorical
21695-382-602169503826060 in 1 BOTTLE, PLASTICHistorical