FDA.reportPublic FDA data

Dexamethasone

Product NDC
43063-266
11-digit product format
430630266
Labeler code
43063
Product ID
43063-266_4137927a-c11c-b316-e063-6294a90a7ca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA087916
Marketing category
ANDA
Marketing start
1982-08-26
Substance
DEXAMETHASONE
Active strength
2 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
DEXAMETHASONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197581

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
43063-266-07Dexamethasone7 in 1 BOTTLE, PLASTICTABLET713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-266-07EA - Each43063-2664d7a7bcd-1319-41ac-94ab-be754c5855c312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-266DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 1 package rows20240507_2ceb3a01-f5bb-4538-b5c1-cea400901d02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197581dexAMETHasone 2 MG Oral TabletPSN2ceb3a01-f5bb-4538-b5c1-cea400901d0213
197581dexamethasone 2 MG Oral TabletSCD2ceb3a01-f5bb-4538-b5c1-cea400901d0213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-266-07430630266077 TABLET in 1 BOTTLE, PLASTIC (43063-266-07) 7 tablet2010-08-030000-00-00NoNoCurrent