FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
72162-1627
11-digit product format
721621627
Labeler code
72162
Product ID
72162-1627_a6caa2b8-b27e-47eb-9db8-ccfa8e8b6a8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
100 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
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
72162-1627-1SPIRONOLACTONE100 in 1 BOTTLETABLET, FILM COATED100107
72162-1627-2SPIRONOLACTONE100 in 1 BOTTLETABLET, FILM COATED100107
72162-1627-3SPIRONOLACTONE30 in 1 BOTTLETABLET, FILM COATED30107
72162-1627-4SPIRONOLACTONE60 in 1 BOTTLETABLET, FILM COATED60107
72162-1627-5SPIRONOLACTONE500 in 1 BOTTLETABLET, FILM COATED500107
72162-1627-6SPIRONOLACTONE60 in 1 BOTTLETABLET, FILM COATED60107
72162-1627-7SPIRONOLACTONE30 in 1 BOTTLETABLET, FILM COATED30107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1627-1EA - Each72162-16271769ba61-70ce-4b9a-a3d4-8413db64b93712024-10-04
72162-1627-3EA - Each72162-162768bf96a2-1ced-4bf4-9413-0cdbd1c8a93612024-10-04
72162-1627-4EA - Each72162-162735fd038c-6bb4-4318-bd3f-085bd1e8a8f012024-11-05
72162-1627-5EA - Each72162-1627dbc08836-0510-410e-b27c-b48c2ae6bfe112024-10-04
72162-1627-6EA - Each72162-1627d5191a10-8279-4cd2-8bbd-1a0346f2dee112024-01-04
72162-1627-7EA - Each72162-1627ad304bc0-9ca7-45c0-96ea-e4ae3315425b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1627SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, 7 package rows20240920_d4cf1136-df3a-4fc2-9a21-9032949eca41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNd4cf1136-df3a-4fc2-9a21-9032949eca41107
198222spironolactone 100 MG Oral TabletSCDd4cf1136-df3a-4fc2-9a21-9032949eca41107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1627-172162162701100 TABLET, FILM COATED in 1 BOTTLE (72162-1627-1) 2023-05-16NoNoHistorical
72162-1627-272162162702100 TABLET, FILM COATED in 1 BOTTLE (72162-1627-2) 2023-05-16NoNoHistorical
72162-1627-37216216270330 TABLET, FILM COATED in 1 BOTTLE (72162-1627-3) 2023-05-16NoNoHistorical
72162-1627-47216216270460 TABLET, FILM COATED in 1 BOTTLE (72162-1627-4) 2023-05-16NoNoHistorical
72162-1627-572162162705500 TABLET, FILM COATED in 1 BOTTLE (72162-1627-5) 2023-05-16NoNoHistorical
72162-1627-67216216270660 in 1 BOTTLEHistorical
72162-1627-77216216270730 TABLET, FILM COATED in 1 BOTTLE (72162-1627-7) 2023-05-16NoNoHistorical