FDA.reportPublic FDA data

Hemady

Product NDC
82111-955
11-digit product format
821110955
Labeler code
82111
Product ID
82111-955_d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
NDA211379
Marketing category
NDA
Marketing start
2019-10-03
Substance
DEXAMETHASONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hemady
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui2261802, 2286261

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
82111-955-01Hemady24 in 1 BOTTLETABLET244
82111-955-01Hemady1 in 1 CARTONTABLET14
82111-955-02Hemady1 in 1 CARTONTABLET14
82111-955-02Hemady100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82111-955-01EA - Each82111-9555843a08b-83f4-49ad-9ae9-05602a72c8a612023-12-05
82111-955-02EA - Each82111-9550ddcc3ea-d0ce-4b9e-9a11-02585096ad7112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82111-955HEMADY (DEXAMETHASONE) TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]3Current NDC, 4 package rows20240606_6b9cf32c-6d60-4853-bbfd-2304ffc2c129.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2261802dexAMETHasone 20 MG Oral TabletPSN6b9cf32c-6d60-4853-bbfd-2304ffc2c1294
2286261HEMADY 20 MG Oral TabletPSN6b9cf32c-6d60-4853-bbfd-2304ffc2c1294
2286261dexamethasone 20 MG Oral Tablet [Hemady]SBD6b9cf32c-6d60-4853-bbfd-2304ffc2c1294
2261802dexamethasone 20 MG Oral TabletSCD6b9cf32c-6d60-4853-bbfd-2304ffc2c1294
2286261Hemady 20 MG Oral TabletSY6b9cf32c-6d60-4853-bbfd-2304ffc2c1294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82111-955-01821110955011 BOTTLE in 1 CARTON (82111-955-01) / 24 TABLET in 1 BOTTLE1 bottle2023-12-01NoNoHistorical
82111-955-02821110955021 BOTTLE in 1 CARTON (82111-955-02) / 100 TABLET in 1 BOTTLE1 bottle2023-12-01NoNoHistorical