FDA.reportPublic FDA data

Decadron

Product NDC
58463-010
11-digit product format
584630010
Labeler code
58463
Product ID
58463-010_37d88d4d-264c-4104-98a4-f4e00013799e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
ELIXIR
Route
ORAL
Labeler
Pragma Pharmaceuticals, LLC
Application
ANDA090891
Marketing category
ANDA
Marketing start
2018-03-15
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
1 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
58463-010-082020-01-31C16284748780-19d75b9d0-ee15-f424-e053-dadaa90a57ceDECADRON ® DEXAMETHASONE ELIXIR, USP (0.5 mg/5 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58463-010-08Decadron237 mL in 1 BOTTLEELIXIR2372

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58463-010-08ML - Milliliter58463-010338b2fad-1456-4190-8853-db833c69dea712018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58463-010DECADRON (DEXAMETHASONE) ELIXIR [PRAGMA PHARMACEUTICALS, LLC]2Legacy NDC, 1 package rows20180315_37a5bdfd-67ab-4ea3-862b-35ac30dfd7f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755976Decadron 0.5 MG in 5 mL Oral SolutionPSN37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42
309686dexAMETHasone 0.5 MG in 5 mL Oral SolutionPSN37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42
755976dexamethasone 0.1 MG/ML Oral Solution [Decadron]SBD37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42
309686dexamethasone 0.1 MG/ML Oral SolutionSCD37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42
755976Decadron 0.1 MG/ML Oral SolutionSY37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42
755976Decadron 0.5 MG per 5 ML Oral SolutionSY37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42
309686dexamethasone 0.5 MG per 5 ML Oral SolutionSY37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42
309686dexamethasone 1 MG per 10 ML Oral SolutionSY37a5bdfd-67ab-4ea3-862b-35ac30dfd7f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58463-010-0858463001008237 mL in 1 BOTTLE237 mlHistorical