Digoxin

Product NDC
10135-748
11-digit product format
101350748
Labeler code
10135
Product ID
10135-748_40a9ac35-555b-4751-e063-6394a90a98aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA215307
Marketing category
ANDA
Marketing start
2022-06-01
Substance
DIGOXIN
Active strength
.25 mg/1
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.25 mg/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
10135-748-01Digoxin100 in 1 BOTTLETABLET1004
10135-748-10Digoxin1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-748-01EA - Each10135-7481fb6b45c-07ac-4afe-8f6a-d6fbd9f5768712022-07-06
10135-748-10EA - Each10135-74813a6e773-1f9f-47d2-8845-88c30a2ac6b512022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-748DIGOXIN TABLET [MARLEX PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20241004_e104c3c5-e4b8-7dbd-e053-2995a90ae339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSNe104c3c5-e4b8-7dbd-e053-2995a90ae3394
197606digoxin 250 MCG Oral TabletPSNe104c3c5-e4b8-7dbd-e053-2995a90ae3394
197604digoxin 0.125 MG Oral TabletSCDe104c3c5-e4b8-7dbd-e053-2995a90ae3394
197606digoxin 0.25 MG Oral TabletSCDe104c3c5-e4b8-7dbd-e053-2995a90ae3394
197604digoxin 125 MCG Oral TabletSYe104c3c5-e4b8-7dbd-e053-2995a90ae3394
197606digoxin 250 MCG Oral TabletSYe104c3c5-e4b8-7dbd-e053-2995a90ae3394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-748-0110135074801100 TABLET in 1 BOTTLE (10135-748-01) 100 tablet2022-06-010000-00-00NoNoCurrent
10135-748-10101350748101000 TABLET in 1 BOTTLE (10135-748-10) 1000 tablet2022-06-010000-00-00NoNoCurrent