FDA.reportPublic FDA data

Dexamethasone

Product NDC
68047-702
11-digit product format
680470702
Labeler code
68047
Product ID
68047-702_4134ccdd-0287-cdf7-e063-6394a90a766d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone 1.5 mg
Dosage form
TABLET
Route
ORAL
Labeler
Larken Laboratories, Inc.
Application
ANDA201270
Marketing category
ANDA
Marketing start
2017-09-01
Substance
DEXAMETHASONE
Active strength
1.5 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
Brand name suffix
1.5 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui197580, 759481, 759697, 846192

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
68047-702-01Dexamethasone1.5 mg100 in 1 BOTTLETABLET10011
68047-702-21Dexamethasone1.5 mg21 in 1 DOSE PACKTABLET2110
68047-702-35Dexamethasone1.5 mg35 in 1 DOSE PACKTABLET3510
68047-702-51Dexamethasone1.5 mg51 in 1 DOSE PACKTABLET5110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68047-702-01EA - Each68047-702480186a3-6d07-490b-be0e-539cdbf9e1c212017-09-11
68047-702-21EA - Each68047-702724de507-da1c-41ea-912d-a2d72d568ee512018-08-13
68047-702-35EA - Each68047-7020b6a0c2b-103d-44d0-8388-06a4de976ac912018-08-13
68047-702-51EA - Each68047-702fcd53bc1-35a1-4f65-b26e-cd11a070129612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68047-702DEXAMETHASONE 1.5 MG TABLET [LARKEN LABORATORIES, INC.]10Current NDC, Legacy NDC, 1 package rows20240614_fcc75691-974e-4a67-b9d7-64dde72b5595.zip
68047-702DEXAMETHASONE 1.5 MG TABLET [LARKEN LABORATORIES, INC.]9Current NDC, Legacy NDC, 3 package rows20240710_7b997c26-e6a3-403c-93fb-b1290cf5dbad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKfcc75691-974e-4a67-b9d7-64dde72b559511
759697{35 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKfcc75691-974e-4a67-b9d7-64dde72b559511
759481{51 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKfcc75691-974e-4a67-b9d7-64dde72b559511
197580dexAMETHasone 1.5 MG Oral TabletPSNfcc75691-974e-4a67-b9d7-64dde72b559511
759697dexAMETHasone 1.5 MG Tablet 10 Day 35 Count PackPSNfcc75691-974e-4a67-b9d7-64dde72b559511
759481dexAMETHasone 1.5 MG Tablet 13 Day 51 Count PackPSNfcc75691-974e-4a67-b9d7-64dde72b559511
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSNfcc75691-974e-4a67-b9d7-64dde72b559511
197580dexamethasone 1.5 MG Oral TabletSCDfcc75691-974e-4a67-b9d7-64dde72b559511
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759697{35 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759481{51 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK7b997c26-e6a3-403c-93fb-b1290cf5dbad10
197580dexAMETHasone 1.5 MG Oral TabletPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759697dexAMETHasone 1.5 MG Tablet 10 Day 35 Count PackPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759481dexAMETHasone 1.5 MG Tablet 13 Day 51 Count PackPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
197580dexamethasone 1.5 MG Oral TabletSCD7b997c26-e6a3-403c-93fb-b1290cf5dbad10
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK42db0356-3948-444c-bda3-1226b4ca89851
197580dexAMETHasone 1.5 MG Oral TabletPSN42db0356-3948-444c-bda3-1226b4ca89851
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSN42db0356-3948-444c-bda3-1226b4ca89851
197580dexamethasone 1.5 MG Oral TabletSCD42db0356-3948-444c-bda3-1226b4ca89851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68047-702-0168047070201100 TABLET in 1 BOTTLE (68047-702-01) 100 tablet2017-09-010000-00-00NoNoCurrent
68047-702-216804707022121 TABLET in 1 DOSE PACK (68047-702-21) 21 tablet2018-08-080000-00-00NoNoCurrent
68047-702-356804707023535 TABLET in 1 DOSE PACK (68047-702-35) 35 tablet2018-08-080000-00-00NoNoCurrent
68047-702-516804707025151 TABLET in 1 DOSE PACK (68047-702-51) 51 tablet2018-08-080000-00-00NoNoCurrent