FDA.reportPublic FDA data

Dexamethasone

Product NDC
70954-398
11-digit product format
709540398
Labeler code
70954
Product ID
70954-398_75141974-8862-4da7-9253-a338cb1fdb84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA215604
Marketing category
ANDA
Marketing start
2023-10-09
Substance
DEXAMETHASONE
Active strength
.5 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
DEXAMETHASONE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197577, 197580, 197581, 197582, 197583, 343033

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
70954-398-10Dexamethasone100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-398-10EA - Each70954-39842e6ec7f-1fdd-4e19-b12f-3898bddd035012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-398DEXAMETHASONE TABLET [ANI PHARMACEUTICALS, INC.]5Current NDC, 1 package rows20240305_fe8cf911-84ef-47be-acb8-0501b546299b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197577dexAMETHasone 0.5 MG Oral TabletPSNfe8cf911-84ef-47be-acb8-0501b546299b5
343033dexAMETHasone 0.75 MG Oral TabletPSNfe8cf911-84ef-47be-acb8-0501b546299b5
197580dexAMETHasone 1.5 MG Oral TabletPSNfe8cf911-84ef-47be-acb8-0501b546299b5
197581dexAMETHasone 2 MG Oral TabletPSNfe8cf911-84ef-47be-acb8-0501b546299b5
197582dexAMETHasone 4 MG Oral TabletPSNfe8cf911-84ef-47be-acb8-0501b546299b5
197583dexAMETHasone 6 MG Oral TabletPSNfe8cf911-84ef-47be-acb8-0501b546299b5
197577dexamethasone 0.5 MG Oral TabletSCDfe8cf911-84ef-47be-acb8-0501b546299b5
343033dexamethasone 0.75 MG Oral TabletSCDfe8cf911-84ef-47be-acb8-0501b546299b5
197580dexamethasone 1.5 MG Oral TabletSCDfe8cf911-84ef-47be-acb8-0501b546299b5
197581dexamethasone 2 MG Oral TabletSCDfe8cf911-84ef-47be-acb8-0501b546299b5
197582dexamethasone 4 MG Oral TabletSCDfe8cf911-84ef-47be-acb8-0501b546299b5
197583dexamethasone 6 MG Oral TabletSCDfe8cf911-84ef-47be-acb8-0501b546299b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-398-1070954039810100 TABLET in 1 BOTTLE (70954-398-10) 100 tablet2023-10-09NoNoHistorical