Dexamethasone

Product NDC
10544-212
11-digit product format
105440212
Labeler code
10544
Product ID
10544-212_3e485ce7-a865-45b1-96c1-cdeed9ec40e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA088238
Marketing category
ANDA
Marketing start
2013-11-15
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
10544-212-062020-01-31C16284748780-19d75b9cf-f08f-f424-e053-dadaa90a57ceDexamethasone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-212-06Dexamethasone6 in 1 BOTTLE, PLASTICTABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-212-06EA - Each10544-212555d7f59-9953-4af0-8991-4ad65c59b36512015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-212DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150317_3e485ce7-a865-45b1-96c1-cdeed9ec40e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197580dexAMETHasone 1.5 MG Oral TabletPSN3e485ce7-a865-45b1-96c1-cdeed9ec40e01
197582dexAMETHasone 4 MG Oral TabletPSN3e485ce7-a865-45b1-96c1-cdeed9ec40e01
197580dexamethasone 1.5 MG Oral TabletSCD3e485ce7-a865-45b1-96c1-cdeed9ec40e01
197582dexamethasone 4 MG Oral TabletSCD3e485ce7-a865-45b1-96c1-cdeed9ec40e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-212-06105440212066 in 1 BOTTLE, PLASTICHistorical