SPIRONOLACTONE

Product NDC
63629-1094
11-digit product format
636291094
Labeler code
63629
Product ID
63629-1094_37122f93-9a22-4ae4-b5c8-040cef92f936
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
100 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
SPIRONOLACTONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198222

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1094-1SPIRONOLACTONE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1094-1EA - Each63629-10949e40153b-7d3d-4f81-ae49-ea6dc262672e12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1094SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 1 package rows20240806_0cc23419-e6d5-4036-8011-dc1d2455e0cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN0cc23419-e6d5-4036-8011-dc1d2455e0cb10
198222spironolactone 100 MG Oral TabletSCD0cc23419-e6d5-4036-8011-dc1d2455e0cb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1094-163629109401500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1094-1) 1986-07-230000-00-00NoNoCurrent