spironolactone

Product NDC
55154-3556
11-digit product format
551543556
Labeler code
55154
Product ID
55154-3556_ef7795d5-c4e7-4db9-8b5a-45284c6f17cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA205936
Marketing category
ANDA
Marketing start
2018-08-15
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
spironolactone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui313096

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-3556-0spironolactone1 in 1 BLISTER PACKTABLET, FILM COATED15
55154-3556-0spironolactone10 in 1 BAGTABLET, FILM COATED105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3556SPIRONOLACTONE TABLET [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20241025_96db5dee-7c01-4f96-8b1e-1fcd2103d0fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN96db5dee-7c01-4f96-8b1e-1fcd2103d0fe5
313096spironolactone 25 MG Oral TabletSCD96db5dee-7c01-4f96-8b1e-1fcd2103d0fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3556-05515435560010 BLISTER PACK in 1 BAG (55154-3556-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2018-08-150000-00-00NoNoCurrent