FDA.reportPublic FDA data

Spironolactone

Product NDC
43063-835
11-digit product format
430630835
Labeler code
43063
Product ID
43063-835_415bbe91-c64a-e288-e063-6294a90af9cb
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
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

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
43063-835-30Spironolactone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
43063-835-90Spironolactone90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-835-30EA - Each43063-835c6fc3efb-5750-40f7-91da-417164c1537412018-03-08
43063-835-90EA - Each43063-835e830a9db-8acf-4eff-bcc4-27889a75b99112018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-835SPIRONOLACTONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20240703_c0efa529-2870-4260-b604-2f30e2cbb87b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNc0efa529-2870-4260-b604-2f30e2cbb87b17
198222spironolactone 100 MG Oral TabletSCDc0efa529-2870-4260-b604-2f30e2cbb87b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-835-304306308353030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-30) 2018-02-130000-00-00NoNoCurrent
43063-835-904306308359090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-90) 2018-03-070000-00-00NoNoCurrent