Spironolactone

Product NDC
72162-1693
11-digit product format
721621693
Labeler code
72162
Product ID
72162-1693_41c5f645-49dc-4cef-b589-3aae109408e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
Substance
SPIRONOLACTONE
Active strength
25 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui313096

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
72162-1693-5Spironolactone500 in 1 BOTTLETABLET, FILM COATED500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1693-5EA - Each72162-169393d7568e-fe27-4f91-8339-04112e64271112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1693SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240829_37b9bc61-2757-454a-935b-752d13eb7eb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN37b9bc61-2757-454a-935b-752d13eb7eb4101
313096spironolactone 25 MG Oral TabletSCD37b9bc61-2757-454a-935b-752d13eb7eb4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1693-572162169305500 TABLET, FILM COATED in 1 BOTTLE (72162-1693-5) 2017-04-04NoNoHistorical