DIGOX

Product NDC
0527-1324
11-digit product format
005271324
Labeler code
0527
Product ID
0527-1324_ed286796-c98c-49a9-96e6-b9fa0ca54195
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA076268
Marketing category
ANDA
Marketing start
2002-07-26
Marketing end
0000-00-00
Substance
DIGOXIN
Active strength
125 ug/1
Pharmacologic classes
Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1324-01EA - Each0527-132445fd6289-6a5c-4a7a-ad0c-556094e69f6212012-07-24
0527-1324-10EA - Each0527-1324df6483c3-593a-4896-8399-defdc2ea7c0a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [REBEL DISTRIBUTORS CORP]1
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIGOXIN TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2DIGOXIN TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIGOXIN TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOXIN TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSNcabd1834-7398-497e-b11f-221a25f21a4e1
197604digoxin 0.125 MG Oral TabletSCDcabd1834-7398-497e-b11f-221a25f21a4e1
197604digoxin 125 MCG Oral TabletSYcabd1834-7398-497e-b11f-221a25f21a4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1324-0100527132401100 TABLET in 1 BOTTLE (0527-1324-01) 100 tablet2002-07-260000-00-00NoNoCurrent
0527-1324-10005271324101000 TABLET in 1 BOTTLE (0527-1324-10) 1000 tablet2002-07-260000-00-00NoNoCurrent