FDA.reportPublic FDA data

Spironolactone

Product NDC
60687-476
11-digit product format
606870476
Labeler code
60687
Product ID
60687-476_24ae6e13-ec56-15c1-e063-6394a90a8845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA205936
Marketing category
ANDA
Marketing start
2019-06-06
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spironolactone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198222, 198223, 313096

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
60687-476-01Spironolactone100 in 1 BOX, UNIT-DOSETABLET1005
60687-476-11Spironolactone1 in 1 BLISTER PACKTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-476-01EA - Each60687-47623bb651a-e05a-4dc5-a8e6-283c9fcb5ebe12019-07-02
60687-476-11EA - Each60687-476c5a19825-29eb-48d7-916f-c9eb4571d98512019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-476SPIRONOLACTONE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241019_bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d5
313096spironolactone 25 MG Oral TabletPSNbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d5
198223spironolactone 50 MG Oral TabletPSNbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d5
198222spironolactone 100 MG Oral TabletSCDbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d5
313096spironolactone 25 MG Oral TabletSCDbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d5
198223spironolactone 50 MG Oral TabletSCDbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-476-0160687047601100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-476-01) / 1 TABLET in 1 BLISTER PACK (60687-476-11) 100 blister pack2019-06-060000-00-00NoNoCurrent
60687-476-11606870476111 in 1 BLISTER PACKHistorical