FDA.reportPublic FDA data

Finasteride

Product NDC
63187-863
11-digit product format
631870863
Labeler code
63187
Product ID
63187-863_fdd2ba1f-49ae-46cb-8c9c-47d2b0d659ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
63187-863-20Finasteride20 in 1 BOTTLETABLET, FILM COATED206
63187-863-30Finasteride30 in 1 BOTTLETABLET, FILM COATED306
63187-863-60Finasteride60 in 1 BOTTLETABLET, FILM COATED606
63187-863-90Finasteride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-863-20EA - Each63187-863538a3c67-715e-47c5-af50-11140d35d26a12022-06-06
63187-863-30EA - Each63187-8631b39838b-c9d2-4d54-bd5c-a5015408910612017-08-11
63187-863-90EA - Each63187-863161ead30-fd79-44c8-8ab8-66610a88158712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-863FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220612_870ab7fe-fff9-4348-b900-213c1cf05f8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-863-206318708632020 TABLET, FILM COATED in 1 BOTTLE (63187-863-20) 2022-02-110000-00-00NoNoCurrent
63187-863-306318708633030 TABLET, FILM COATED in 1 BOTTLE (63187-863-30) 2017-06-010000-00-00NoNoCurrent
63187-863-606318708636060 TABLET, FILM COATED in 1 BOTTLE (63187-863-60) 2017-06-010000-00-00NoNoCurrent
63187-863-906318708639090 TABLET, FILM COATED in 1 BOTTLE (63187-863-90) 2017-06-010000-00-00NoNoCurrent