FDA.reportPublic FDA data

Dexamethasone

Product NDC
63629-3742
11-digit product format
636293742
Labeler code
63629
Product ID
63629-3742_ce3eeaa7-3b4f-455a-ae01-f592db862382
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA084612
Marketing category
ANDA
Marketing start
1978-07-19
Substance
DEXAMETHASONE
Active strength
4 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
DEXAMETHASONE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197582

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
63629-3742-02020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-12020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-22020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-32020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-42020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-52020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-62020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-72020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-82020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-92020-02-25C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-02019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-12019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-22019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-32019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-42019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-52019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-62019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-72019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-82019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)
63629-3742-92019-11-27C16284748780-19855e2a2-5079-60a7-e053-dbdaa90a05bdDexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3742-0Dexamethasone4 in 1 BOTTLETABLET41003
63629-3742-1Dexamethasone30 in 1 BOTTLETABLET301003
63629-3742-2Dexamethasone6 in 1 BOTTLETABLET61003
63629-3742-3Dexamethasone3 in 1 BOTTLETABLET31003
63629-3742-4Dexamethasone15 in 1 BOTTLETABLET151003
63629-3742-5Dexamethasone40 in 1 BOTTLETABLET401003
63629-3742-6Dexamethasone60 in 1 BOTTLETABLET601003
63629-3742-7Dexamethasone28 in 1 BOTTLETABLET281003
63629-3742-8Dexamethasone90 in 1 BOTTLETABLET901003
63629-3742-9Dexamethasone10 in 1 BOTTLETABLET101003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3742-1EA - Each63629-3742987959b6-d0cf-4265-a0cb-6f7d421344e712013-02-13
63629-3742-2EA - Each63629-3742df1733cc-cc1f-4915-b35c-60d58fc4616b12013-02-13
63629-3742-3EA - Each63629-3742716233dc-beec-46a7-a616-8ae6bf5bf3e412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001
SUCROSEINACTIVE INGREDIENTC151H8M554DEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3742DEXAMETHASONE TABLET [BRYANT RANCH PREPACK]1003Current NDC, Legacy NDC, 10 package rows20200226_89e570c9-3e64-433b-9779-b94332f2b5ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSN89e570c9-3e64-433b-9779-b94332f2b5ef1003
197582dexamethasone 4 MG Oral TabletSCD89e570c9-3e64-433b-9779-b94332f2b5ef1003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3742-0636293742004 TABLET in 1 BOTTLE (63629-3742-0) 4 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-16362937420130 TABLET in 1 BOTTLE (63629-3742-1) 30 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-2636293742026 TABLET in 1 BOTTLE (63629-3742-2) 6 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-3636293742033 TABLET in 1 BOTTLE (63629-3742-3) 3 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-46362937420415 TABLET in 1 BOTTLE (63629-3742-4) 15 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-56362937420540 TABLET in 1 BOTTLE (63629-3742-5) 40 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-66362937420660 TABLET in 1 BOTTLE (63629-3742-6) 60 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-76362937420728 TABLET in 1 BOTTLE (63629-3742-7) 28 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-86362937420890 TABLET in 1 BOTTLE (63629-3742-8) 90 tablet2008-07-070000-00-00NoNoCurrent
63629-3742-96362937420910 TABLET in 1 BOTTLE (63629-3742-9) 10 tablet2008-07-070000-00-00NoNoCurrent