Finasteride

Product NDC
16729-089
11-digit product format
167290089
Labeler code
16729
Product ID
16729-089_2397604d-3fd8-2d97-e063-6394a90a0750
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA091643
Marketing category
ANDA
Marketing start
2013-11-08
Substance
FINASTERIDE
Active strength
1 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
FINASTERIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57GNO57U7G
Rxcui200172

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
16729-089-10Finasteride30 in 1 BOTTLETABLET, FILM COATED3010
16729-089-15Finasteride90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-089FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]10Current NDC, Legacy NDC, 2 package rows20241004_e3728709-e805-4b46-9954-2c433a865987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSNe3728709-e805-4b46-9954-2c433a86598710
200172finasteride 1 MG Oral TabletSCDe3728709-e805-4b46-9954-2c433a86598710
200172FIN5C 1 MG Oral TabletSYe3728709-e805-4b46-9954-2c433a86598710
200172finasteride 1 MG Oral TabletPSN870ab7fe-fff9-4348-b900-213c1cf05f8e6
200172finasteride 1 MG Oral TabletSCD870ab7fe-fff9-4348-b900-213c1cf05f8e6
200172FIN5C 1 MG Oral TabletSY870ab7fe-fff9-4348-b900-213c1cf05f8e6
200172finasteride 1 MG Oral TabletPSN5f26924c-8b02-0baa-e053-2991aa0acce04
200172finasteride 1 MG Oral TabletSCD5f26924c-8b02-0baa-e053-2991aa0acce04
200172FIN5C 1 MG Oral TabletSY5f26924c-8b02-0baa-e053-2991aa0acce04
200172finasteride 1 MG Oral TabletPSN976be3a0-71a7-40eb-a70c-e07968f15b553
200172finasteride 1 MG Oral TabletSCD976be3a0-71a7-40eb-a70c-e07968f15b553
200172FIN5C 1 MG Oral TabletSY976be3a0-71a7-40eb-a70c-e07968f15b553
200172finasteride 1 MG Oral TabletPSN23376932-2728-4d0b-b8ee-d32966c1eade2
200172finasteride 1 MG Oral TabletSCD23376932-2728-4d0b-b8ee-d32966c1eade2
200172FIN5C 1 MG Oral TabletSY23376932-2728-4d0b-b8ee-d32966c1eade2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-089-101672900891030 TABLET, FILM COATED in 1 BOTTLE (16729-089-10) 2013-11-080000-00-00NoNoCurrent
16729-089-151672900891590 TABLET, FILM COATED in 1 BOTTLE (16729-089-15) 2014-01-170000-00-00NoNoCurrent