FDA.reportPublic FDA data

Spironolactone

Product NDC
82804-976
11-digit product format
828040976
Labeler code
82804
Product ID
82804-976_99b119e3-537a-464c-9376-4219bf283753
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040750
Marketing category
ANDA
Marketing start
2021-01-04
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
82804-976-00Spironolactone100 in 1 BOTTLETABLET, COATED1001
82804-976-11Spironolactone1000 in 1 BOTTLETABLET, COATED10001
82804-976-30Spironolactone30 in 1 BOTTLETABLET, COATED301
82804-976-55Spironolactone500 in 1 BOTTLETABLET, COATED5001
82804-976-60Spironolactone60 in 1 BOTTLETABLET, COATED601
82804-976-72Spironolactone120 in 1 BOTTLETABLET, COATED1201
82804-976-90Spironolactone90 in 1 BOTTLETABLET, COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-976SPIRONOLACTONE TABLET, COATED [PROFICIENT RX LP]1Current NDC, 7 package rows20250216_99b119e3-537a-464c-9376-4219bf283753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN99b119e3-537a-464c-9376-4219bf2837531
313096spironolactone 25 MG Oral TabletPSN99b119e3-537a-464c-9376-4219bf2837531
198223spironolactone 50 MG Oral TabletPSN99b119e3-537a-464c-9376-4219bf2837531
198222spironolactone 100 MG Oral TabletSCD99b119e3-537a-464c-9376-4219bf2837531
313096spironolactone 25 MG Oral TabletSCD99b119e3-537a-464c-9376-4219bf2837531
198223spironolactone 50 MG Oral TabletSCD99b119e3-537a-464c-9376-4219bf2837531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-976-0082804097600100 TABLET, COATED in 1 BOTTLE (82804-976-00) 2025-02-13NoNoCurrent
82804-976-11828040976111000 TABLET, COATED in 1 BOTTLE (82804-976-11) 2025-02-13NoNoCurrent
82804-976-308280409763030 TABLET, COATED in 1 BOTTLE (82804-976-30) 2025-02-13NoNoCurrent
82804-976-5582804097655500 TABLET, COATED in 1 BOTTLE (82804-976-55) 2025-02-13NoNoCurrent
82804-976-608280409766060 TABLET, COATED in 1 BOTTLE (82804-976-60) 2025-02-13NoNoCurrent
82804-976-7282804097672120 TABLET, COATED in 1 BOTTLE (82804-976-72) 2025-02-13NoNoCurrent
82804-976-908280409769090 TABLET, COATED in 1 BOTTLE (82804-976-90) 2025-02-13NoNoCurrent