Digoxin

Product NDC
0404-9850
11-digit product format
004049850
Labeler code
0404
Product ID
0404-9850_a8ec9757-c9a4-4b96-af0b-1689696766ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA083391
Marketing category
ANDA
Marketing start
2022-01-10
Substance
DIGOXIN
Active strength
.25 mg/mL
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
DIGOXIN.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui104208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
20d84de3-cb46-44c4-9211-63e833fa2688Product name220221214
4d74103a-bb9b-9034-fbc8-dac635e6e729Product name320221117
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9850-02Digoxin2 mL in 1 AMPULEINJECTION27
0404-9850-02Digoxin1 in 1 BAGINJECTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9850DIGOXIN INJECTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20240402_98d2ad5b-9ffa-4456-9a01-567636c3a4d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104208digoxin 500 MCG in 2 ML InjectionPSN98d2ad5b-9ffa-4456-9a01-567636c3a4d27
1042082 ML digoxin 0.25 MG/ML InjectionSCD98d2ad5b-9ffa-4456-9a01-567636c3a4d27
104208digoxin 500 MCG per 2 ML InjectionSY98d2ad5b-9ffa-4456-9a01-567636c3a4d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9850-02004049850021 AMPULE in 1 BAG (0404-9850-02) / 2 mL in 1 AMPULE1 ampule2022-01-100000-00-00NoNoCurrent