SPIRONOLACTONE

Product NDC
63629-1062
11-digit product format
636291062
Labeler code
63629
Product ID
63629-1062_b54616fa-faf0-409d-b61e-42f53d8addf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
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
63629-1062-1SPIRONOLACTONE500 in 1 BOTTLE, PLASTICTABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1062-1EA - Each63629-1062590571c7-ce5d-4ab3-a6eb-6c21b4ad280012020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1062SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 1 package rows20240806_d6138536-cdc1-4459-84ff-9dedc0de1105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNd6138536-cdc1-4459-84ff-9dedc0de110510
313096spironolactone 25 MG Oral TabletSCDd6138536-cdc1-4459-84ff-9dedc0de110510
313096spironolactone 25 MG Oral TabletPSNfb961096-edbb-45ad-96b7-61c2f9b98cf92
313096spironolactone 25 MG Oral TabletSCDfb961096-edbb-45ad-96b7-61c2f9b98cf92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1062-163629106201500 TABLET in 1 BOTTLE, PLASTIC (63629-1062-1) 500 tablet1986-07-230000-00-00NoNoCurrent