FDA.reportPublic FDA data

Spironolactone

Product NDC
82804-975
11-digit product format
828040975
Labeler code
82804
Product ID
82804-975_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
25 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
SPIRONOLACTONE25 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
82804-975-00Spironolactone100 in 1 BOTTLETABLET, COATED1001
82804-975-11Spironolactone1000 in 1 BOTTLETABLET, COATED10001
82804-975-30Spironolactone30 in 1 BOTTLETABLET, COATED301
82804-975-55Spironolactone500 in 1 BOTTLETABLET, COATED5001
82804-975-60Spironolactone60 in 1 BOTTLETABLET, COATED601
82804-975-72Spironolactone120 in 1 BOTTLETABLET, COATED1201
82804-975-90Spironolactone90 in 1 BOTTLETABLET, COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-975-00EA - Each82804-9753cdfee3d-8baf-40f0-88cb-17d856eeaff912025-03-04
82804-975-11EA - Each82804-975b469e1c7-ee4c-4181-83bf-ec0199b9f60712025-03-04
82804-975-30EA - Each82804-97501bf69c4-0ff2-42f6-ba6e-59dc75bfae3f12025-03-04
82804-975-55EA - Each82804-97550b7231e-46bc-4f8d-8992-83ed5fb5f8cf12025-03-04
82804-975-60EA - Each82804-975761efbac-d25b-45d9-aeff-fdbf5758083912025-03-04
82804-975-72EA - Each82804-975e0bdb2be-d017-4ae3-8693-1367129b6f8f12025-03-04
82804-975-90EA - Each82804-975c3cad722-7e8e-4316-8b20-3763c8da8a4512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-975SPIRONOLACTONE 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
82804-975-0082804097500100 TABLET, COATED in 1 BOTTLE (82804-975-00) 2025-02-13NoNoHistorical
82804-975-11828040975111000 TABLET, COATED in 1 BOTTLE (82804-975-11) 2025-02-13NoNoHistorical
82804-975-308280409753030 TABLET, COATED in 1 BOTTLE (82804-975-30) 2025-02-13NoNoHistorical
82804-975-5582804097555500 TABLET, COATED in 1 BOTTLE (82804-975-55) 2025-02-13NoNoHistorical
82804-975-608280409756060 TABLET, COATED in 1 BOTTLE (82804-975-60) 2025-02-13NoNoHistorical
82804-975-7282804097572120 TABLET, COATED in 1 BOTTLE (82804-975-72) 2025-02-13NoNoHistorical
82804-975-908280409759090 TABLET, COATED in 1 BOTTLE (82804-975-90) 2025-02-13NoNoHistorical