FDA.reportPublic FDA data

spironolactone

Product NDC
70771-1029
11-digit product format
707711029
Labeler code
70771
Product ID
70771-1029_038310cc-d190-4868-9442-00f7222d0597
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205936
Marketing category
ANDA
Marketing start
2018-08-15
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, 198223, 313096

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
70771-1029-0spironolactone1000 in 1 BOTTLETABLET, FILM COATED10008
70771-1029-1spironolactone100 in 1 BOTTLETABLET, FILM COATED1008
70771-1029-3spironolactone30 in 1 BOTTLETABLET, FILM COATED308
70771-1029-4spironolactone10 in 1 BLISTER PACKTABLET, FILM COATED108
70771-1029-4spironolactone10 in 1 CARTONTABLET, FILM COATED108
70771-1029-5spironolactone500 in 1 BOTTLETABLET, FILM COATED5008
70771-1029-9spironolactone90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1029SPIRONOLACTONE TABLET [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 7 package rows20230919_963af399-feb7-49d2-a59c-c19edad9c682.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN963af399-feb7-49d2-a59c-c19edad9c6828
313096spironolactone 25 MG Oral TabletPSN963af399-feb7-49d2-a59c-c19edad9c6828
198223spironolactone 50 MG Oral TabletPSN963af399-feb7-49d2-a59c-c19edad9c6828
198222spironolactone 100 MG Oral TabletSCD963af399-feb7-49d2-a59c-c19edad9c6828
313096spironolactone 25 MG Oral TabletSCD963af399-feb7-49d2-a59c-c19edad9c6828
198223spironolactone 50 MG Oral TabletSCD963af399-feb7-49d2-a59c-c19edad9c6828

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1029-0707711029001000 TABLET, FILM COATED in 1 BOTTLE (70771-1029-0) 2018-08-150000-00-00NoNoCurrent
70771-1029-170771102901100 TABLET, FILM COATED in 1 BOTTLE (70771-1029-1) 2018-08-150000-00-00NoNoCurrent
70771-1029-37077110290330 TABLET, FILM COATED in 1 BOTTLE (70771-1029-3) 2018-08-150000-00-00NoNoCurrent
70771-1029-47077110290410 BLISTER PACK in 1 CARTON (70771-1029-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2018-08-150000-00-00NoNoCurrent
70771-1029-570771102905500 TABLET, FILM COATED in 1 BOTTLE (70771-1029-5) 2018-08-150000-00-00NoNoCurrent
70771-1029-97077110290990 TABLET, FILM COATED in 1 BOTTLE (70771-1029-9) 2018-08-150000-00-00NoNoCurrent