FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
0574-1133
11-digit product format
005741133
Labeler code
0574
Product ID
0574-1133_902035fb-dba8-4fdf-9d8d-29d736c07d57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Padagis US LLC
Application
NDA209478
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-10-31
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-1133-04SPIRONOLACTONE118 mL in 1 BOTTLESUSPENSION1183
0574-1133-05SPIRONOLACTONE5 mL in 1 CUP, UNIT-DOSESUSPENSION53
0574-1133-10SPIRONOLACTONE10 in 1 CARTONSUSPENSION103
0574-1133-16SPIRONOLACTONE473 mL in 1 BOTTLESUSPENSION4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-1133SPIRONOLACTONE SUSPENSION [PADAGIS US LLC]3Current NDC, 4 package rows20250103_522bd365-ddcc-48f4-8a98-66dc4c3bb314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104232spironolactone 25 MG in 5 mL Oral SuspensionPSN122558a0-57bb-4195-9adf-d37b049cbfb56
104232spironolactone 5 MG/ML Oral SuspensionSCD122558a0-57bb-4195-9adf-d37b049cbfb56
104232spironolactone 25 MG per 5 ML Oral SuspensionSY122558a0-57bb-4195-9adf-d37b049cbfb56
104232spironolactone 25 MG in 5 mL Oral SuspensionPSN522bd365-ddcc-48f4-8a98-66dc4c3bb3143
104232spironolactone 5 MG/ML Oral SuspensionSCD522bd365-ddcc-48f4-8a98-66dc4c3bb3143
104232spironolactone 25 MG per 5 ML Oral SuspensionSY522bd365-ddcc-48f4-8a98-66dc4c3bb3143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0574-1133-0400574113304118 mL in 1 BOTTLE (0574-1133-04) 118 ml2023-10-31NoNoCurrent
0574-1133-05005741133055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0574-1133-100057411331010 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05) 2023-10-31NoNoCurrent
0574-1133-1600574113316473 mL in 1 BOTTLE (0574-1133-16) 473 ml2023-10-31NoNoCurrent