DEXAMETHASONE 6-Day

Product NDC
42195-721
11-digit product format
421950721
Labeler code
42195
Product ID
42195-721_275ee21a-fc1f-46bb-b1de-1804aba00511
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE
Dosage form
TABLET
Route
ORAL
Labeler
Xspire Pharma, Llc
Application
ANDA088237
Marketing category
ANDA
Marketing start
2020-05-07
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
2 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
42195-721-212024-01-30C16284748780-11030e364-fb2b-111a-e063-dadaa90a10e2DEXAMETHASONE TABLETS USP, 1.5 mg THERAPY PACK 6-Day Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42195-721-21DEXAMETHASONE 6-Day21 in 1 BLISTER PACKTABLET212
42195-721-21DEXAMETHASONE 6-Day1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42195-721DEXAMETHASONE 6-DAY (DEXAMETHASONE) TABLET [XSPIRE PHARMA, LLC]2Legacy NDC, 2 package rows20220119_efaeb61c-ad51-41e7-a2ba-84d8db186ff1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKefaeb61c-ad51-41e7-a2ba-84d8db186ff12
197580dexAMETHasone 1.5 MG Oral TabletPSNefaeb61c-ad51-41e7-a2ba-84d8db186ff12
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSNefaeb61c-ad51-41e7-a2ba-84d8db186ff12
197580dexamethasone 1.5 MG Oral TabletSCDefaeb61c-ad51-41e7-a2ba-84d8db186ff12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42195-721-21421950721211 BLISTER PACK in 1 CARTON (42195-721-21) > 21 TABLET in 1 BLISTER PACK1 blister pack2020-05-070000-00-00NoNoCurrent