Digoxin

Product NDC
82685-202
11-digit product format
826850202
Labeler code
82685
Product ID
82685-202_48481a34-0b24-a796-e063-6294a90af307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Oliva Therapeutics, LLC
Application
ANDA076268
Marketing category
ANDA
Marketing start
2022-09-01
Substance
DIGOXIN
Active strength
250 ug/1
Pharmacologic classes
Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Digoxin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN250 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui197604, 197606

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20d84de3-cb46-44c4-9211-63e833fa2688Product name220221214
4d74103a-bb9b-9034-fbc8-dac635e6e729Product name320221117
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82685-202-01Digoxin100 in 1 BOTTLETABLET1004
82685-202-10Digoxin1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82685-202-01EA - Each82685-202b4910a1d-dfb2-40bb-beda-f12701ced3af12023-08-08
82685-202-10EA - Each82685-2020d0bd650-2b7c-470b-85ec-c9019452858c12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82685-202DIGOXIN TABLET [OLIVA THERAPEUTICS, LLC]3Current NDC, Legacy NDC, 2 package rows20230630_5b2d10d0-6e9d-4c39-a025-6b2f30ff6243.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197606digoxin 250 MCG Oral TabletPSNdcf9b23b-5840-46ff-bb61-c57a02831a03104
197606digoxin 0.25 MG Oral TabletSCDdcf9b23b-5840-46ff-bb61-c57a02831a03104
197606digoxin 250 MCG Oral TabletSYdcf9b23b-5840-46ff-bb61-c57a02831a03104
197606digoxin 250 MCG Oral TabletPSN03612934-62f4-4002-85af-6c66cd172acb100
197606digoxin 0.25 MG Oral TabletSCD03612934-62f4-4002-85af-6c66cd172acb100
197606digoxin 250 MCG Oral TabletSY03612934-62f4-4002-85af-6c66cd172acb100
197604digoxin 125 MCG Oral TabletPSN5b2d10d0-6e9d-4c39-a025-6b2f30ff62434
197606digoxin 250 MCG Oral TabletPSN5b2d10d0-6e9d-4c39-a025-6b2f30ff62434
197604digoxin 0.125 MG Oral TabletSCD5b2d10d0-6e9d-4c39-a025-6b2f30ff62434
197606digoxin 0.25 MG Oral TabletSCD5b2d10d0-6e9d-4c39-a025-6b2f30ff62434
197604digoxin 125 MCG Oral TabletSY5b2d10d0-6e9d-4c39-a025-6b2f30ff62434
197606digoxin 250 MCG Oral TabletSY5b2d10d0-6e9d-4c39-a025-6b2f30ff62434
197606digoxin 250 MCG Oral TabletPSN42d079a7-def1-4220-b71f-db2651966ffe1
197606digoxin 0.25 MG Oral TabletSCD42d079a7-def1-4220-b71f-db2651966ffe1
197606digoxin 250 MCG Oral TabletSY42d079a7-def1-4220-b71f-db2651966ffe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82685-202-0182685020201100 TABLET in 1 BOTTLE (82685-202-01) 100 tablet2022-09-010000-00-00NoNoCurrent
82685-202-10826850202101000 TABLET in 1 BOTTLE (82685-202-10) 1000 tablet2022-09-010000-00-00NoNoCurrent