Spironolactone

Product NDC
72162-1694
11-digit product format
721621694
Labeler code
72162
Product ID
72162-1694_818e4d5d-d5cf-46a3-acd9-3609f344cd2e
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
50 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
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
72162-1694-1Spironolactone100 in 1 BOTTLETABLET, FILM COATED100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1694-1EA - Each72162-16946b97d034-3d1b-4c1b-bcf3-b6a7a8b9e27312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1694SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240829_b5b129b8-aed9-4d94-a35e-e92647effbdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSNb5b129b8-aed9-4d94-a35e-e92647effbdb101
198223spironolactone 50 MG Oral TabletSCDb5b129b8-aed9-4d94-a35e-e92647effbdb101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1694-172162169401100 TABLET, FILM COATED in 1 BOTTLE (72162-1694-1) 2017-04-04NoNoHistorical