FDA.reportPublic FDA data

Dexamethasone

Product NDC
63187-561
11-digit product format
631870561
Labeler code
63187
Product ID
63187-561_64c0e623-ed7a-4168-83e4-8cd3905d06aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-561-00Dexamethasone100 in 1 BOTTLE, PLASTICTABLET1007
63187-561-10Dexamethasone10 in 1 BOTTLE, PLASTICTABLET107
63187-561-15Dexamethasone15 in 1 BOTTLE, PLASTICTABLET157
63187-561-24Dexamethasone24 in 1 BOTTLE, PLASTICTABLET247
63187-561-30Dexamethasone30 in 1 BOTTLE, PLASTICTABLET307
63187-561-60Dexamethasone60 in 1 BOTTLE, PLASTICTABLET607
63187-561-90Dexamethasone90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-561DEXAMETHASONE TABLET [PROFICIENT RX LP]7Current NDC, Legacy NDC, 7 package rows20220622_99296e80-3ca6-4430-9ef7-adca357c31b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSN99296e80-3ca6-4430-9ef7-adca357c31b37
197582dexamethasone 4 MG Oral TabletSCD99296e80-3ca6-4430-9ef7-adca357c31b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-561-0063187056100100 TABLET in 1 BOTTLE, PLASTIC (63187-561-00) 100 tablet2015-10-010000-00-00NoNoCurrent
63187-561-106318705611010 TABLET in 1 BOTTLE, PLASTIC (63187-561-10) 10 tablet2016-10-030000-00-00NoNoCurrent
63187-561-156318705611515 TABLET in 1 BOTTLE, PLASTIC (63187-561-15) 15 tablet2019-09-010000-00-00NoNoCurrent
63187-561-246318705612424 TABLET in 1 BOTTLE, PLASTIC (63187-561-24) 24 tablet2015-10-010000-00-00NoNoCurrent
63187-561-306318705613030 TABLET in 1 BOTTLE, PLASTIC (63187-561-30) 30 tablet2015-10-010000-00-00NoNoCurrent
63187-561-606318705616060 TABLET in 1 BOTTLE, PLASTIC (63187-561-60) 60 tablet2015-10-010000-00-00NoNoCurrent
63187-561-906318705619090 TABLET in 1 BOTTLE, PLASTIC (63187-561-90) 90 tablet2015-10-010000-00-00NoNoCurrent