Digoxin

Product NDC
69292-605
11-digit product format
692920605
Labeler code
69292
Product ID
69292-605_6ea84176-ac4e-47c6-b65c-c203e6e8de98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
SOLUTION
Route
ORAL
Labeler
Amici Pharma, Inc
Application
ANDA215209
Marketing category
ANDA
Marketing start
2022-06-10
Substance
DIGOXIN
Active strength
.05 mg/mL
Pharmacologic classes
Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Digoxin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui393245

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
69292-605-60Digoxin1 in 1 CARTONSOLUTION16
69292-605-60Digoxin60 mL in 1 BOTTLESOLUTION606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-605-60ML - Milliliter69292-605dbe1cfb6-8ed3-47cc-ab7b-fced78b7a70312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-605DIGOXIN SOLUTION [AMICI PHARMA, INC]5Current NDC, Legacy NDC, 2 package rows20250402_eda7193a-e139-41d5-a11b-dc6241645995.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
393245digoxin 0.05 MG in 1 mL Oral SolutionPSNeda7193a-e139-41d5-a11b-dc62416459956
393245digoxin 0.05 MG/ML Oral SolutionSCDeda7193a-e139-41d5-a11b-dc62416459956
393245digoxin 50 MCG per 1 ML Oral SOlutionSYeda7193a-e139-41d5-a11b-dc62416459956
393245digoxin 50 MCG/ML Oral SolutionSYeda7193a-e139-41d5-a11b-dc62416459956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69292-605-60692920605601 BOTTLE in 1 CARTON (69292-605-60) / 60 mL in 1 BOTTLE1 bottle2022-06-100000-00-00NoNoCurrent