FDA.reportPublic FDA data

dexamethasone

Product NDC
60219-2044
11-digit product format
602192044
Labeler code
60219
Product ID
60219-2044_574d26cb-6ade-4619-be52-ef855081c8da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA215106
Marketing category
ANDA
Marketing start
2021-09-01
Substance
DEXAMETHASONE
Active strength
6 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
DEXAMETHASONE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197582, 197583

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
60219-2044-1dexamethasone100 in 1 BOTTLE, PLASTICTABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2044-1EA - Each60219-2044edcd7bcc-8411-4ec8-ae73-27f4b19fa0c812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-2044DEXAMETHASONE TABLET [AMNEAL PHARMACEUTICALS NY LLC]9Current NDC, Legacy NDC, 1 package rows20240717_ac71f888-c83a-46a5-921c-1ebdf6cfadc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSNac71f888-c83a-46a5-921c-1ebdf6cfadc19
197583dexAMETHasone 6 MG Oral TabletPSNac71f888-c83a-46a5-921c-1ebdf6cfadc19
197582dexamethasone 4 MG Oral TabletSCDac71f888-c83a-46a5-921c-1ebdf6cfadc19
197583dexamethasone 6 MG Oral TabletSCDac71f888-c83a-46a5-921c-1ebdf6cfadc19
197582dexAMETHasone 4 MG Oral TabletPSN64b46398-9b97-45e8-b1ba-1a202d5744485
197583dexAMETHasone 6 MG Oral TabletPSN4c619d48-8cf9-4085-8405-c8f066bce19c5
197583dexAMETHasone 6 MG Oral TabletPSN64b46398-9b97-45e8-b1ba-1a202d5744485
197582dexamethasone 4 MG Oral TabletSCD64b46398-9b97-45e8-b1ba-1a202d5744485
197583dexamethasone 6 MG Oral TabletSCD4c619d48-8cf9-4085-8405-c8f066bce19c5
197583dexamethasone 6 MG Oral TabletSCD64b46398-9b97-45e8-b1ba-1a202d5744485
197583dexAMETHasone 6 MG Oral TabletPSNf4c0fde4-dc39-6c3a-e053-2995a90a50d62
197583dexamethasone 6 MG Oral TabletSCDf4c0fde4-dc39-6c3a-e053-2995a90a50d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-2044-160219204401100 TABLET in 1 BOTTLE, PLASTIC (60219-2044-1) 100 tablet2021-09-010000-00-00NoNoCurrent