FDA.reportPublic FDA data

DIGOX

Product NDC
53217-005
11-digit product format
532170005
Labeler code
53217
Product ID
53217-005_8da49cda-f1fa-4227-9892-57f67235f68b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076268
Marketing category
ANDA
Marketing start
2002-07-26
Marketing end
0000-00-00
Substance
DIGOXIN
Active strength
250 ug/1
Pharmacologic classes
Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-005-302020-01-31C16284748780-19d75b9d0-4a11-f424-e053-dadaa90a57ceDIGOX (Digoxin Tablets, USP) 125 mcg (0.125 mg) 250 mcg (0.25 mg)
53217-005-602020-01-31C16284748780-19d75b9d0-4a11-f424-e053-dadaa90a57ceDIGOX (Digoxin Tablets, USP) 125 mcg (0.125 mg) 250 mcg (0.25 mg)
53217-005-902020-01-31C16284748780-19d75b9d0-4a11-f424-e053-dadaa90a57ceDIGOX (Digoxin Tablets, USP) 125 mcg (0.125 mg) 250 mcg (0.25 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-005-30DIGOX30 in 1 BOTTLE, PLASTICTABLET301
53217-005-60DIGOX60 in 1 BOTTLE, PLASTICTABLET601
53217-005-90DIGOX90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-005-30EA - Each53217-005c6346acb-b734-4e6c-a16c-c3585cd5951c12015-10-02
53217-005-60EA - Each53217-005aec47594-cc63-4f66-aef3-56f5530d334912015-10-02
53217-005-90EA - Each53217-0052731adaf-f0f7-47ee-8269-a16d21f31afb12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
DIGOXINACTIVE MOIETY73K4184T59DIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-005DIGOX (DIGOXIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140214_fccefc9c-ea90-47c1-8b4b-45f987b438ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245373Digox 250 MCG Oral TabletPSNfccefc9c-ea90-47c1-8b4b-45f987b438ca1
197606digoxin 250 MCG Oral TabletPSNfccefc9c-ea90-47c1-8b4b-45f987b438ca1
1245373digoxin 0.25 MG Oral Tablet [Digox]SBDfccefc9c-ea90-47c1-8b4b-45f987b438ca1
197606digoxin 0.25 MG Oral TabletSCDfccefc9c-ea90-47c1-8b4b-45f987b438ca1
1245373Digox 0.25 MG Oral TabletSYfccefc9c-ea90-47c1-8b4b-45f987b438ca1
1245373Digox 250 MCG Oral TabletSYfccefc9c-ea90-47c1-8b4b-45f987b438ca1
197606digoxin 250 MCG Oral TabletSYfccefc9c-ea90-47c1-8b4b-45f987b438ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-005-305321700053030 in 1 BOTTLE, PLASTICHistorical
53217-005-605321700056060 in 1 BOTTLE, PLASTICHistorical
53217-005-905321700059090 in 1 BOTTLE, PLASTICHistorical