FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
63629-1064
11-digit product format
636291064
Labeler code
63629
Product ID
63629-1064_1458652c-ce89-4720-82c4-7f771bd44fc3
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
63629-1064-1SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET3015
63629-1064-2SPIRONOLACTONE60 in 1 BOTTLE, PLASTICTABLET6015
63629-1064-3SPIRONOLACTONE90 in 1 BOTTLE, PLASTICTABLET9015
63629-1064-4SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1064-1EA - Each63629-106459fa66a2-87de-4f5a-914b-8726ffa5b85a12020-07-13
63629-1064-2EA - Each63629-106440efc3fc-bc69-4d2a-aceb-411666364e5112020-07-13
63629-1064-3EA - Each63629-10643d7c249c-b989-4911-bff9-8afb9b0d909512020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1064SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 4 package rows20240806_b98b7780-e310-493a-83bd-bb3d93cf8dde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNb98b7780-e310-493a-83bd-bb3d93cf8dde15
313096spironolactone 25 MG Oral TabletSCDb98b7780-e310-493a-83bd-bb3d93cf8dde15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1064-16362910640130 TABLET in 1 BOTTLE, PLASTIC (63629-1064-1) 30 tablet2020-09-150000-00-00NoNoCurrent
63629-1064-26362910640260 TABLET in 1 BOTTLE, PLASTIC (63629-1064-2) 60 tablet2020-09-210000-00-00NoNoCurrent
63629-1064-36362910640390 TABLET in 1 BOTTLE, PLASTIC (63629-1064-3) 90 tablet2020-09-210000-00-00NoNoCurrent
63629-1064-463629106404100 TABLET in 1 BOTTLE, PLASTIC (63629-1064-4) 100 tablet2023-05-16NoNoHistorical