FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
63629-4094
11-digit product format
636294094
Labeler code
63629
Product ID
63629-4094_0e68cdd6-df1b-40f6-84a0-7a7d48b6cf23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SPIRONOLACTONE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4094-12020-10-16C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-22020-10-16C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-32020-10-16C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-42020-10-16C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-52020-10-16C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-12020-01-31C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-22020-01-31C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-32020-01-31C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-42020-01-31C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
63629-4094-52020-01-31C16284748780-19d75b9d0-63c1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4094-1SPIRONOLACTONE100 in 1 BOTTLETABLET, FILM COATED1001011
63629-4094-2SPIRONOLACTONE3 in 1 BOTTLETABLET, FILM COATED31011
63629-4094-3SPIRONOLACTONE30 in 1 BOTTLETABLET, FILM COATED301011
63629-4094-4SPIRONOLACTONE90 in 1 BOTTLETABLET, FILM COATED901011
63629-4094-5SPIRONOLACTONE60 in 1 BOTTLETABLET, FILM COATED601011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4094-1EA - Each63629-4094f8137b2b-d164-4aaf-88c9-c9503f959f4912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4094SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1010Current NDC, Legacy NDC, 5 package rows20230407_b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNb7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d1011
198222spironolactone 100 MG Oral TabletSCDb7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d1011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4094-163629409401100 TABLET, FILM COATED in 1 BOTTLE (63629-4094-1) 2009-10-260000-00-00NoNoCurrent
63629-4094-2636294094023 TABLET, FILM COATED in 1 BOTTLE (63629-4094-2) 2023-03-060000-00-00NoNoCurrent
63629-4094-36362940940330 TABLET, FILM COATED in 1 BOTTLE (63629-4094-3) 2016-11-280000-00-00NoNoCurrent
63629-4094-46362940940490 TABLET, FILM COATED in 1 BOTTLE (63629-4094-4) 2022-02-170000-00-00NoNoCurrent
63629-4094-56362940940560 TABLET, FILM COATED in 1 BOTTLE (63629-4094-5) 2021-10-060000-00-00NoNoCurrent