FDA.reportPublic FDA data

Dexamethasone

Product NDC
67296-1413
11-digit product format
672961413
Labeler code
67296
Product ID
67296-1413_b95bac1b-60e4-628a-e053-2a95a90a7d76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA088316
Marketing category
ANDA
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
6 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1413-12026-01-29C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-22026-01-29C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-42026-01-29C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-12024-08-07C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-22024-08-07C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-42024-08-07C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-12023-01-30C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-22023-01-30C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG
67296-1413-42023-01-30C16284748780-1f386c64a-2ff2-0266-e053-dadaa90a7c1aDexamethasone Tablets 6MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1413-1Dexamethasone10 in 1 BOTTLETABLET102
67296-1413-2Dexamethasone2 in 1 BOTTLETABLET22
67296-1413-4Dexamethasone4 in 1 BOTTLETABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1413DEXAMETHASONE TABLET [REDPHARM DRUG, INC.]2Legacy NDC, 3 package rows20240808_b95ba990-1f3e-5be1-e053-2995a90a6068.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197583dexAMETHasone 6 MG Oral TabletPSNb95ba990-1f3e-5be1-e053-2995a90a60682
197583dexamethasone 6 MG Oral TabletSCDb95ba990-1f3e-5be1-e053-2995a90a60682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1413-16729614130110 TABLET in 1 BOTTLE (67296-1413-1) 10 tablet2021-01-010000-00-00NoNoCurrent
67296-1413-2672961413022 TABLET in 1 BOTTLE (67296-1413-2) 2 tablet2021-01-010000-00-00NoNoCurrent
67296-1413-4672961413044 TABLET in 1 BOTTLE (67296-1413-4) 4 tablet2021-01-010000-00-00NoNoCurrent