LANOXIN

Product NDC
70515-261
11-digit product format
705150261
Labeler code
70515
Product ID
70515-261_415f97e2-9ce0-b282-e063-6394a90ab0a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
digoxin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Covis Pharma US, Inc
Application
NDA009330
Marketing category
NDA
Marketing start
2019-10-29
Substance
DIGOXIN
Active strength
250 ug/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
LANOXIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui104208, 204504, 208135, 208137

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
70515-261-10LANOXIN2 mL in 1 VIALINJECTION, SOLUTION210
70515-261-10LANOXIN10 in 1 BOXINJECTION, SOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70515-261-10ML - Milliliter70515-2616704a97f-4eff-4470-88a4-53a4369219b412020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70515-261LANOXIN (DIGOXIN) INJECTION, SOLUTION [COVIS PHARMA US, INC]9Current NDC, Legacy NDC, 2 package rows20250115_9ec84cac-6ecc-43dc-8006-6ccc029e2707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204504digoxin 100 MCG in 1 ML InjectionPSN9ec84cac-6ecc-43dc-8006-6ccc029e270710
104208digoxin 500 MCG in 2 ML InjectionPSN9ec84cac-6ecc-43dc-8006-6ccc029e270710
208137LANOXIN 500 MCG in 2 ML InjectionPSN9ec84cac-6ecc-43dc-8006-6ccc029e270710
208135LANOXIN Pediatric 100 MCG in 1 ML InjectionPSN9ec84cac-6ecc-43dc-8006-6ccc029e270710
2081351 ML digoxin 0.1 MG/ML Injection [Lanoxin]SBD9ec84cac-6ecc-43dc-8006-6ccc029e270710
2081372 ML digoxin 0.25 MG/ML Injection [Lanoxin]SBD9ec84cac-6ecc-43dc-8006-6ccc029e270710
2045041 ML digoxin 0.1 MG/ML InjectionSCD9ec84cac-6ecc-43dc-8006-6ccc029e270710
1042082 ML digoxin 0.25 MG/ML InjectionSCD9ec84cac-6ecc-43dc-8006-6ccc029e270710
204504digoxin 100 MCG per 1 ML InjectionSY9ec84cac-6ecc-43dc-8006-6ccc029e270710
104208digoxin 500 MCG per 2 ML InjectionSY9ec84cac-6ecc-43dc-8006-6ccc029e270710
208135Lanoxin 100 MCG per 1 ML InjectionSY9ec84cac-6ecc-43dc-8006-6ccc029e270710
208137Lanoxin 500 MCG per 2 ML InjectionSY9ec84cac-6ecc-43dc-8006-6ccc029e270710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70515-261-107051502611010 VIAL in 1 BOX (70515-261-10) / 2 mL in 1 VIAL10 vial2019-10-290000-00-00NoNoCurrent