FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
63629-1830
11-digit product format
636291830
Labeler code
63629
Product ID
63629-1830_520b62af-6437-4600-a765-346cf1586071
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
25 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
SPIRONOLACTONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui313096

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1830-12020-10-16C16284748780-19d75b9d0-0b68-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
63629-1830-22020-10-16C16284748780-19d75b9d0-0b68-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
63629-1830-32020-10-16C16284748780-19d75b9d0-0b68-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
63629-1830-42020-10-16C16284748780-19d75b9d0-0b68-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
63629-1830-52020-10-16C16284748780-19d75b9d0-0b68-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
63629-1830-62020-10-16C16284748780-19d75b9d0-0b68-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
63629-1830-12020-01-31C16284748780-19d75b9d0-0b68-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
63629-1830-22020-01-31C16284748780-19d75b9d0-0b68-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
63629-1830-32020-01-31C16284748780-19d75b9d0-0b68-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
63629-1830-42020-01-31C16284748780-19d75b9d0-0b68-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
63629-1830-52020-01-31C16284748780-19d75b9d0-0b68-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
63629-1830-62020-01-31C16284748780-19d75b9d0-0b68-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
63629-1830-1SPIRONOLACTONE30 in 1 BOTTLETABLET3014
63629-1830-2SPIRONOLACTONE60 in 1 BOTTLETABLET6014
63629-1830-3SPIRONOLACTONE90 in 1 BOTTLETABLET9014
63629-1830-4SPIRONOLACTONE14 in 1 BOTTLETABLET1414
63629-1830-5SPIRONOLACTONE100 in 1 BOTTLETABLET10014
63629-1830-6SPIRONOLACTONE7 in 1 BOTTLETABLET714
63629-1830-7SPIRONOLACTONE10 in 1 BOTTLETABLET1014
63629-1830-8SPIRONOLACTONE180 in 1 BOTTLETABLET18014
63629-1830-9SPIRONOLACTONE45 in 1 BOTTLETABLET4514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1830-1EA - Each63629-1830233b145f-3857-4aa7-bc6c-0ae88ededa6812012-07-24
63629-1830-2EA - Each63629-1830a464c793-83dd-4769-9646-4b19d51ccbd112012-07-24
63629-1830-3EA - Each63629-183084d6edb6-0bba-4ad8-b17a-e5206808bcc512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1830SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 9 package rows20230406_2efb4720-625f-6616-b6f0-8b13a17c9d7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN2efb4720-625f-6616-b6f0-8b13a17c9d7e14
313096spironolactone 25 MG Oral TabletSCD2efb4720-625f-6616-b6f0-8b13a17c9d7e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1830-16362918300130 TABLET in 1 BOTTLE (63629-1830-1) 30 tablet2009-08-240000-00-00NoNoCurrent
63629-1830-26362918300260 TABLET in 1 BOTTLE (63629-1830-2) 60 tablet2010-02-120000-00-00NoNoCurrent
63629-1830-36362918300390 TABLET in 1 BOTTLE (63629-1830-3) 90 tablet2014-04-080000-00-00NoNoCurrent
63629-1830-46362918300414 TABLET in 1 BOTTLE (63629-1830-4) 14 tablet2010-04-060000-00-00NoNoCurrent
63629-1830-563629183005100 TABLET in 1 BOTTLE (63629-1830-5) 100 tablet2013-04-100000-00-00NoNoCurrent
63629-1830-6636291830067 TABLET in 1 BOTTLE (63629-1830-6) 7 tablet2023-03-010000-00-00NoNoCurrent
63629-1830-76362918300710 TABLET in 1 BOTTLE (63629-1830-7) 10 tablet2023-03-010000-00-00NoNoCurrent
63629-1830-863629183008180 TABLET in 1 BOTTLE (63629-1830-8) 180 tablet2023-03-01NoNoHistorical
63629-1830-96362918300945 TABLET in 1 BOTTLE (63629-1830-9) 45 tablet2023-03-01NoNoHistorical