FDA.reportPublic FDA data

Spironolactone

Product NDC
69238-2027
11-digit product format
692382027
Labeler code
69238
Product ID
69238-2027_e25b36dd-7948-4481-8994-13658f1f337f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA215572
Marketing category
ANDA
Marketing start
2023-09-08
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
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2027-2Spironolactone473 mL in 1 BOTTLESUSPENSION4736
69238-2027-8Spironolactone118 mL in 1 BOTTLESUSPENSION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2027SPIRONOLACTONE SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, 2 package rows20230908_1ed9a2cb-d666-43db-b515-f9615fa6da25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104232spironolactone 25 MG in 5 mL Oral SuspensionPSN1ed9a2cb-d666-43db-b515-f9615fa6da256
104232spironolactone 5 MG/ML Oral SuspensionSCD1ed9a2cb-d666-43db-b515-f9615fa6da256
104232spironolactone 25 MG per 5 ML Oral SuspensionSY1ed9a2cb-d666-43db-b515-f9615fa6da256
104232spironolactone 25 MG in 5 mL Oral SuspensionPSNe01d6fec-f74f-4087-9322-e2ed6dfe62c51
104232spironolactone 5 MG/ML Oral SuspensionSCDe01d6fec-f74f-4087-9322-e2ed6dfe62c51
104232spironolactone 25 MG per 5 ML Oral SuspensionSYe01d6fec-f74f-4087-9322-e2ed6dfe62c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2027-269238202702473 mL in 1 BOTTLE (69238-2027-2) 473 ml2023-09-08NoNoHistorical
69238-2027-869238202708118 mL in 1 BOTTLE (69238-2027-8) 118 ml2023-09-08NoNoHistorical