Spironolactone

Product NDC
21695-766
11-digit product format
216950766
Labeler code
21695
Product ID
21695-766_90668e5a-0c0d-4941-94cf-8b2fba410ed7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-766-302019-09-24C16284748780-1934fe258-4ae5-48b1-e053-8cdaa90a720aSPIRONOLACTONE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-766-30Spironolactone30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-766-30EA - Each21695-766ceb8c301-0b91-46f5-9fec-aac541d554bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SpironolactoneACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
SpironolactoneACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-766SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101210_90668e5a-0c0d-4941-94cf-8b2fba410ed7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN90668e5a-0c0d-4941-94cf-8b2fba410ed71
313096spironolactone 25 MG Oral TabletSCD90668e5a-0c0d-4941-94cf-8b2fba410ed71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-766-302169507663030 in 1 BOTTLE, PLASTICHistorical