FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
72162-1626
11-digit product format
721621626
Labeler code
72162
Product ID
72162-1626_bfe78069-1785-4ba7-a2f6-71e8966976c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
50 mg/1
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
SPIRONOLACTONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198223

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
72162-1626-1SPIRONOLACTONE100 in 1 BOTTLETABLET, FILM COATED100104
72162-1626-3SPIRONOLACTONE30 in 1 BOTTLETABLET, FILM COATED30104
72162-1626-5SPIRONOLACTONE500 in 1 BOTTLETABLET, FILM COATED500104
72162-1626-6SPIRONOLACTONE60 in 1 BOTTLETABLET, FILM COATED60104
72162-1626-9SPIRONOLACTONE90 in 1 BOTTLETABLET, FILM COATED90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1626-1EA - Each72162-1626607192f6-2db9-4033-adae-deae15bc08c712024-10-04
72162-1626-3EA - Each72162-1626c972d227-64a4-467b-8cfa-e7bfa96c308912024-10-04
72162-1626-5EA - Each72162-162626eb7929-2a02-430e-8145-054a3cee945a12023-07-06
72162-1626-6EA - Each72162-1626490ee1ed-24e4-4d6e-8c8e-f2ff7e622f0a12024-10-04
72162-1626-9EA - Each72162-1626243d4fbc-8580-40b2-ab8b-edad22a00e5512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1626SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 5 package rows20250529_cbc817de-5ea8-4139-9c13-02bac8ff93c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSNcbc817de-5ea8-4139-9c13-02bac8ff93c3104
198223spironolactone 50 MG Oral TabletSCDcbc817de-5ea8-4139-9c13-02bac8ff93c3104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1626-172162162601100 TABLET, FILM COATED in 1 BOTTLE (72162-1626-1) 2026-03-27NoNoHistorical
72162-1626-37216216260330 TABLET, FILM COATED in 1 BOTTLE (72162-1626-3) 2026-03-27NoNoHistorical
72162-1626-572162162605500 TABLET, FILM COATED in 1 BOTTLE (72162-1626-5) 2026-03-27NoNoHistorical
72162-1626-67216216260660 TABLET, FILM COATED in 1 BOTTLE (72162-1626-6) 2026-03-27NoNoHistorical
72162-1626-97216216260990 TABLET, FILM COATED in 1 BOTTLE (72162-1626-9) 2026-03-27NoNoHistorical