FDA.reportPublic FDA data

Dexamethasone

Product NDC
66993-730
11-digit product format
669930730
Labeler code
66993
Product ID
66993-730_64545c32-2309-4fa4-9d9e-bfecf16244b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Prasco Laboratories
Application
ANDA080399
Marketing category
ANDA
Marketing start
2022-04-30
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
66993-730-02Dexamethasone100 in 1 BOTTLETABLET1008
66993-730-51Dexamethasone10 in 1 BLISTER PACKTABLET108
66993-730-80Dexamethasone10 in 1 CARTONTABLET108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-730-02EA - Each66993-730b6403221-6a42-4067-82f5-f75c50469fa512022-05-04
66993-730-51EA - Each66993-7303cd8ebfa-4088-4e81-a452-916e5f11a41f12023-05-05
66993-730-80EA - Each66993-73024b6fa85-7d4b-4635-8fc7-a69cdd54874712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-730DEXAMETHASONE TABLET [PRASCO LABORATORIES]7Current NDC, Legacy NDC, 3 package rows20241020_bfce6b49-f7ff-4ec7-9580-b730f0a207d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSNbfce6b49-f7ff-4ec7-9580-b730f0a207d78
197582dexamethasone 4 MG Oral TabletSCDbfce6b49-f7ff-4ec7-9580-b730f0a207d78
197582dexAMETHasone 4 MG Oral TabletPSN89af5591-eebf-44e7-827f-ce3b123123e45
197582dexamethasone 4 MG Oral TabletSCD89af5591-eebf-44e7-827f-ce3b123123e45
197582dexAMETHasone 4 MG Oral TabletPSN16c59e9a-8e4f-4300-bbbb-bcc982c18fc84
197582dexamethasone 4 MG Oral TabletSCD16c59e9a-8e4f-4300-bbbb-bcc982c18fc84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-730-0266993073002100 TABLET in 1 BOTTLE (66993-730-02) 100 tablet2022-04-300000-00-00NoNoCurrent
66993-730-516699307305110 in 1 BLISTER PACKHistorical
66993-730-806699307308010 BLISTER PACK in 1 CARTON (66993-730-80) / 10 TABLET in 1 BLISTER PACK (66993-730-51) 10 blister pack2023-04-030000-00-00NoNoCurrent