FDA.reportPublic FDA data

spironolactone

Product NDC
31722-691
11-digit product format
317220691
Labeler code
31722
Product ID
31722-691_3241a29b-82b9-fd3a-e063-6294a90aa46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218085
Marketing category
ANDA
Marketing start
2025-02-21
Substance
SPIRONOLACTONE
Active strength
25 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui104232

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-691-11spironolactone118 mL in 1 BOTTLESUSPENSION1181
31722-691-47spironolactone473 mL in 1 BOTTLESUSPENSION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-691-11ML - Milliliter31722-691407709a8-6552-467b-a7f4-5da9edc93b8912025-09-12
31722-691-47ML - Milliliter31722-6917244f342-fc40-42d8-8bda-f81a209f24a412025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-691SPIRONOLACTONE (SPIRONOLACTONE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250410_4ac2926a-949a-4383-b0b0-92c0822dfcda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104232spironolactone 25 MG in 5 mL Oral SuspensionPSN4ac2926a-949a-4383-b0b0-92c0822dfcda1
104232spironolactone 5 MG/ML Oral SuspensionSCD4ac2926a-949a-4383-b0b0-92c0822dfcda1
104232spironolactone 25 MG per 5 ML Oral SuspensionSY4ac2926a-949a-4383-b0b0-92c0822dfcda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-691-1131722069111118 mL in 1 BOTTLE (31722-691-11) 118 ml2025-02-21NoNoCurrent
31722-691-4731722069147473 mL in 1 BOTTLE (31722-691-47) 473 ml2025-02-21NoNoCurrent