FDA.reportPublic FDA data

Dexamethasone

Product NDC
68788-8763
11-digit product format
687888763
Labeler code
68788
Product ID
68788-8763_86f71920-d9ff-41d1-a70e-b90c446f6db6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216282
Marketing category
ANDA
Marketing start
2024-11-11
Substance
DEXAMETHASONE
Active strength
.75 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
Dexamethasone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE.75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui343033

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
68788-8763-0Dexamethasone100 in 1 BOTTLETABLET1002
68788-8763-1Dexamethasone12 in 1 BOTTLETABLET122
68788-8763-2Dexamethasone21 in 1 BOTTLETABLET212
68788-8763-3Dexamethasone30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8763-0EA - Each68788-876373b37d2c-7deb-428c-966c-e729ce80b51812025-02-10
68788-8763-1EA - Each68788-87632cbcf06f-719b-4db2-87d1-69b48817d90412025-02-10
68788-8763-2EA - Each68788-8763bd7d0917-7dfc-4946-9fe8-091d2e72eb0012025-02-10
68788-8763-3EA - Each68788-87634e9107e1-bc1f-41cb-b0d3-9f5bef02d97312025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8763DEXAMETHASONE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20241113_64577454-d49e-4180-99e6-8461f74b0221.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
343033dexAMETHasone 0.75 MG Oral TabletPSN64577454-d49e-4180-99e6-8461f74b02212
343033dexamethasone 0.75 MG Oral TabletSCD64577454-d49e-4180-99e6-8461f74b02212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8763-068788876300100 TABLET in 1 BOTTLE (68788-8763-0) 100 tablet2024-11-11NoNoHistorical
68788-8763-16878887630112 TABLET in 1 BOTTLE (68788-8763-1) 12 tablet2024-11-11NoNoHistorical
68788-8763-26878887630221 TABLET in 1 BOTTLE (68788-8763-2) 21 tablet2024-11-11NoNoHistorical
68788-8763-36878887630330 TABLET in 1 BOTTLE (68788-8763-3) 30 tablet2024-11-11NoNoHistorical