FDA.reportPublic FDA data

Spironolactone

Product NDC
10544-523
11-digit product format
105440523
Labeler code
10544
Product ID
10544-523_0efe0854-7a72-10cd-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA091426
Marketing category
ANDA
Marketing start
2013-10-02
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
10544-523-302020-01-31C16284748780-19d75b9d0-8659-f424-e053-dadaa90a57ceSpironolactone Tablets, USP
10544-523-902020-01-31C16284748780-19d75b9d0-8659-f424-e053-dadaa90a57ceSpironolactone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-523-30Spironolactone30 in 1 BOTTLETABLET302
10544-523-90Spironolactone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-523-30EA - Each10544-5237bb87a4b-0587-4546-8b0a-c78f82b31ce312015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-523SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 2 package rows20150213_0ef98e7e-88c4-05c6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN0ef98e7e-88c4-05c6-e054-00144ff8d46c2
313096spironolactone 25 MG Oral TabletSCD0ef98e7e-88c4-05c6-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-523-301054405233030 in 1 BOTTLEHistorical
10544-523-901054405239090 in 1 BOTTLEHistorical