SPIRONOLACTONE

Product NDC
63629-1093
11-digit product format
636291093
Labeler code
63629
Product ID
63629-1093_8d935d14-d23a-48f6-b53e-2e5613e789c0
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
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1093-1SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1093-1EA - Each63629-1093add3dca8-d189-4938-9b2e-9da22d54c35312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1093SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 1 package rows20240820_66c46ede-4f56-436a-993b-006b4eb56fc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN66c46ede-4f56-436a-993b-006b4eb56fc310
198222spironolactone 100 MG Oral TabletSCD66c46ede-4f56-436a-993b-006b4eb56fc310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1093-16362910930130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1093-1) 1986-07-230000-00-00NoNoCurrent