FDA.reportPublic FDA data

Dexamethasone

Product NDC
63629-7806
11-digit product format
636297806
Labeler code
63629
Product ID
63629-7806_4a25abaa-862a-43f7-a3cc-4cfb056e6743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088316
Marketing category
ANDA
Marketing start
1983-09-15
Substance
DEXAMETHASONE
Active strength
6 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197579, 197583, 343033

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7806-1Dexamethasone30 in 1 BOTTLETABLET301020
63629-7806-2Dexamethasone4 in 1 BOTTLETABLET41020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXAMETHASONE TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]3
SUCROSEINACTIVE INGREDIENTC151H8M554DEXAMETHASONE TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7806DEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1020Current NDC, Legacy NDC, 2 package rows20200919_a9fd2013-0797-4ec4-82c5-07d282522625.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
343033dexAMETHasone 0.75 MG Oral TabletPSNa9fd2013-0797-4ec4-82c5-07d2825226251020
197579dexAMETHasone 1 MG Oral TabletPSNa9fd2013-0797-4ec4-82c5-07d2825226251020
197583dexAMETHasone 6 MG Oral TabletPSNa9fd2013-0797-4ec4-82c5-07d2825226251020
343033dexamethasone 0.75 MG Oral TabletSCDa9fd2013-0797-4ec4-82c5-07d2825226251020
197579dexamethasone 1 MG Oral TabletSCDa9fd2013-0797-4ec4-82c5-07d2825226251020
197583dexamethasone 6 MG Oral TabletSCDa9fd2013-0797-4ec4-82c5-07d2825226251020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7806-16362978060130 TABLET in 1 BOTTLE (63629-7806-1) 30 tablet2018-09-250000-00-00NoNoCurrent
63629-7806-2636297806024 TABLET in 1 BOTTLE (63629-7806-2) 4 tablet2018-09-250000-00-00NoNoCurrent