FDA.reportPublic FDA data

Dexamethasone

Product NDC
60432-466
11-digit product format
604320466
Labeler code
60432
Product ID
60432-466_e7571c15-0616-4951-8562-1e11b3d1baad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
ELIXIR
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA088254
Marketing category
ANDA
Marketing start
1983-07-27
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60432-466-082025-11-21C16284748780-1f386c64a-44ee-0266-e053-dadaa90a7c1ac6eb10d2-2251-482b-8a57-fea31c05bc7e
60432-466-082023-01-30C16284748780-1f386c64a-44ee-0266-e053-dadaa90a7c1ac6eb10d2-2251-482b-8a57-fea31c05bc7e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-466-08ML - Milliliter60432-466dbfadd5e-b1e2-4b63-ae6c-433d54aae0db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DexamethasoneACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
AlcoholINACTIVE INGREDIENT3K9958V90MDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
RaspberryINACTIVE INGREDIENT4N14V5R27WDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
SucroseINACTIVE INGREDIENTC151H8M554DEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-466DEXAMETHASONE ELIXIR [MORTON GROVE PHARMACEUTICALS, INC.]3Legacy NDC20181222_c6eb10d2-2251-482b-8a57-fea31c05bc7e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60432-466-08604320466081 BOTTLE, GLASS in 1 BOX (60432-466-08) > 237 mL in 1 BOTTLE, GLASS1983-07-270000-00-00NoNoCurrent