FDA.reportPublic FDA data

spironolactone

Product NDC
31722-094
11-digit product format
317220094
Labeler code
31722
Product ID
31722-094_3d3f731e-28d0-d9b4-e063-6394a90ad1fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217761
Marketing category
ANDA
Marketing start
2025-07-25
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
31722-094-01spironolactone100 in 1 BOTTLETABLET, FILM COATED1001
31722-094-05spironolactone500 in 1 BOTTLETABLET, FILM COATED5001
31722-094-10spironolactone1000 in 1 BOTTLETABLET, FILM COATED10001
31722-094-30spironolactone30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-094-01EA - Each31722-0940fb5ee70-7913-400f-aa4a-be9fcca8194412026-01-08
31722-094-05EA - Each31722-0943725c654-7e05-4a81-819d-c38860c8688312026-01-08
31722-094-10EA - Each31722-094937fcc58-98d5-4fa5-aef7-8c3930c4b3ca12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNe61269b2-823a-49e8-b55f-ef0b8b1dbcde1
313096spironolactone 25 MG Oral TabletPSNe61269b2-823a-49e8-b55f-ef0b8b1dbcde1
198223spironolactone 50 MG Oral TabletPSNe61269b2-823a-49e8-b55f-ef0b8b1dbcde1
198222spironolactone 100 MG Oral TabletSCDe61269b2-823a-49e8-b55f-ef0b8b1dbcde1
313096spironolactone 25 MG Oral TabletSCDe61269b2-823a-49e8-b55f-ef0b8b1dbcde1
198223spironolactone 50 MG Oral TabletSCDe61269b2-823a-49e8-b55f-ef0b8b1dbcde1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-094-0131722009401100 TABLET, FILM COATED in 1 BOTTLE (31722-094-01) 2025-07-25NoNoHistorical
31722-094-0531722009405500 TABLET, FILM COATED in 1 BOTTLE (31722-094-05) 2025-07-25NoNoHistorical
31722-094-10317220094101000 TABLET, FILM COATED in 1 BOTTLE (31722-094-10) 2025-07-25NoNoHistorical
31722-094-303172200943030 TABLET, FILM COATED in 1 BOTTLE (31722-094-30) 2025-07-25NoNoHistorical