Digoxin

Product NDC
70954-200
11-digit product format
709540200
Labeler code
70954
Product ID
70954-200_ee465d1a-f5ee-477b-b20e-3ce8705e7472
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA215307
Marketing category
ANDA
Marketing start
2022-08-25
Substance
DIGOXIN
Active strength
.0625 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.0625 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui197604, 197606, 245273

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
70954-200-10Digoxin100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-200-10EA - Each70954-2006c01665a-602d-45a7-853c-a38f000742e312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-200DIGOXIN TABLET [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240511_dba3b3f7-3ff2-4996-8653-b0e54a398bf9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSNdba3b3f7-3ff2-4996-8653-b0e54a398bf94
197606digoxin 250 MCG Oral TabletPSNdba3b3f7-3ff2-4996-8653-b0e54a398bf94
245273digoxin 62.5 MCG Oral TabletPSNdba3b3f7-3ff2-4996-8653-b0e54a398bf94
245273digoxin 0.0625 MG Oral TabletSCDdba3b3f7-3ff2-4996-8653-b0e54a398bf94
197604digoxin 0.125 MG Oral TabletSCDdba3b3f7-3ff2-4996-8653-b0e54a398bf94
197606digoxin 0.25 MG Oral TabletSCDdba3b3f7-3ff2-4996-8653-b0e54a398bf94
197604digoxin 125 MCG Oral TabletSYdba3b3f7-3ff2-4996-8653-b0e54a398bf94
197606digoxin 250 MCG Oral TabletSYdba3b3f7-3ff2-4996-8653-b0e54a398bf94
245273digoxin 62.5 MCG Oral TabletSYdba3b3f7-3ff2-4996-8653-b0e54a398bf94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-200-1070954020010100 TABLET in 1 BOTTLE (70954-200-10) 100 tablet2022-08-250000-00-00NoNoCurrent