FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
71205-830
11-digit product format
712050830
Labeler code
71205
Product ID
71205-830_416ce231-fc8d-4ba0-a1ce-d5e054cf025e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
50 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
SPIRONOLACTONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198223

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
71205-830-30SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
71205-830-60SPIRONOLACTONE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
71205-830-90SPIRONOLACTONE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-830-30EA - Each71205-83005ec411d-35d7-40d3-a09a-ffdb1f11754012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-830SPIRONOLACTONE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230825_416ce231-fc8d-4ba0-a1ce-d5e054cf025e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSN416ce231-fc8d-4ba0-a1ce-d5e054cf025e1
198223spironolactone 50 MG Oral TabletSCD416ce231-fc8d-4ba0-a1ce-d5e054cf025e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-830-307120508303030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-830-30) 2023-08-18NoNoCurrent
71205-830-607120508306060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-830-60) 2023-08-18NoNoCurrent
71205-830-907120508309090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-830-90) 2023-08-18NoNoCurrent