FDA.reportPublic FDA data

Spironolactone

Product NDC
43063-832
11-digit product format
430630832
Labeler code
43063
Product ID
43063-832_525ac2f1-7053-88ff-e063-6294a90adcb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA203512
Marketing category
ANDA
Marketing start
2017-06-02
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
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-832-01Spironolactone100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
43063-832-30Spironolactone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3020
43063-832-60Spironolactone60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020
43063-832-90Spironolactone90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-832-01EA - Each43063-8327bcbb575-cfbd-420f-982c-e0cbc9894bf712018-03-08
43063-832-30EA - Each43063-832962515d3-edf0-4f51-a0c7-389d6ccfe0b312018-06-11
43063-832-60EA - Each43063-832543d381d-6905-41cc-8a16-fe9bd3a5c89012019-07-02
43063-832-90EA - Each43063-832e2235386-ebe8-447d-961d-b66b445331c912019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-832SPIRONOLACTONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 4 package rows20240703_c223a334-7383-429f-b8e3-a21200f16962.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNc223a334-7383-429f-b8e3-a21200f1696220
313096spironolactone 25 MG Oral TabletSCDc223a334-7383-429f-b8e3-a21200f1696220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-832-0143063083201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-832-01) 2018-01-310000-00-00NoNoCurrent
43063-832-304306308323030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-832-30) 2018-01-310000-00-00NoNoCurrent
43063-832-604306308326060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-832-60) 2018-06-120000-00-00NoNoCurrent
43063-832-904306308329090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-832-90) 2018-01-310000-00-00NoNoCurrent