FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
17856-1133
11-digit product format
178561133
Labeler code
17856
Product ID
17856-1133_51b65bde-7a04-754d-e063-6394a90ad796
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SPIRONOLACTONE
Listing expiration
2027-12-31

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
17856-1133-1SPIRONOLACTONE2.5 mL in 1 SYRINGESUSPENSION2.56
17856-1133-1SPIRONOLACTONE1 in 1 BAGSUSPENSION16
17856-1133-4SPIRONOLACTONE2.5 mL in 1 SYRINGESUSPENSION2.56
17856-1133-4SPIRONOLACTONE1 in 1 BAGSUSPENSION16
17856-1133-5SPIRONOLACTONE1 mL in 1 SYRINGESUSPENSION16
17856-1133-5SPIRONOLACTONE120 in 1 CASESUSPENSION1206
17856-1133-6SPIRONOLACTONE3 mL in 1 SYRINGESUSPENSION36
17856-1133-6SPIRONOLACTONE120 in 1 CASESUSPENSION1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1133SPIRONOLACTONE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]1Current NDC, 8 package rows20240605_122558a0-57bb-4195-9adf-d37b049cbfb5.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1133-1178561133011 SYRINGE in 1 BAG (17856-1133-1) / 2.5 mL in 1 SYRINGE1 syringe2024-06-03NoNoHistorical
17856-1133-4178561133041 SYRINGE in 1 BAG (17856-1133-4) / 2.5 mL in 1 SYRINGE1 syringe2025-09-26NoNoHistorical
17856-1133-517856113305120 SYRINGE in 1 CASE (17856-1133-5) / 1 mL in 1 SYRINGE120 syringe2026-04-30NoNoHistorical
17856-1133-617856113306120 SYRINGE in 1 CASE (17856-1133-6) / 3 mL in 1 SYRINGE120 syringe2026-04-30NoNoHistorical