FDA.reportPublic FDA data

Finasteride

Product NDC
71335-0433
11-digit product format
713350433
Labeler code
71335
Product ID
71335-0433_965d1a37-d574-4894-b08e-c6f21b882379
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090121
Marketing category
ANDA
Marketing start
2010-05-28
Substance
FINASTERIDE
Active strength
5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINASTERIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57GNO57U7G
Rxcui310346

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
d00474ae-23eb-a8eb-bf56-520e590cc6dbProduct name220170406
0f90664c-9d0e-f046-dc6a-73563cd8347eProduct name220170405

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0433-1Finasteride100 in 1 BOTTLETABLET, FILM COATED1009
71335-0433-2Finasteride30 in 1 BOTTLETABLET, FILM COATED309
71335-0433-3Finasteride60 in 1 BOTTLETABLET, FILM COATED609
71335-0433-4Finasteride90 in 1 BOTTLETABLET, FILM COATED909
71335-0433-5Finasteride500 in 1 BOTTLETABLET, FILM COATED5009
71335-0433-6Finasteride180 in 1 BOTTLETABLET, FILM COATED1809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0433-1EA - Each71335-0433a60e36bc-2cd4-4d11-b555-60ce5b0236f012018-03-08
71335-0433-2EA - Each71335-04332c73690e-9edc-49fe-bb6d-0b37af39b92f12018-03-08
71335-0433-3EA - Each71335-043394d941e3-1c8f-41cd-b364-88281f4c62bb12018-03-08
71335-0433-4EA - Each71335-0433bd1e3524-ab62-4d1e-92a0-505b4b63d02d12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0433FINASTERIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 6 package rows20241110_ef9c0b23-4736-4fb0-862c-c2a4d644e0d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNef9c0b23-4736-4fb0-862c-c2a4d644e0d69
310346finasteride 5 MG Oral TabletSCDef9c0b23-4736-4fb0-862c-c2a4d644e0d69
310346FIN5C 5 MG Oral TabletSYef9c0b23-4736-4fb0-862c-c2a4d644e0d69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0433-171335043301100 TABLET, FILM COATED in 1 BOTTLE (71335-0433-1) 2021-12-160000-00-00NoNoCurrent
71335-0433-27133504330230 TABLET, FILM COATED in 1 BOTTLE (71335-0433-2) 2018-03-140000-00-00NoNoCurrent
71335-0433-37133504330360 TABLET, FILM COATED in 1 BOTTLE (71335-0433-3) 2021-01-270000-00-00NoNoCurrent
71335-0433-47133504330490 TABLET, FILM COATED in 1 BOTTLE (71335-0433-4) 2018-05-030000-00-00NoNoCurrent
71335-0433-571335043305500 TABLET, FILM COATED in 1 BOTTLE (71335-0433-5) 2018-05-210000-00-00NoNoCurrent
71335-0433-671335043306180 TABLET, FILM COATED in 1 BOTTLE (71335-0433-6) 2024-10-300000-00-00NoNoCurrent