FDA.reportPublic FDA data

Finasteride

Product NDC
71205-767
11-digit product format
712050767
Labeler code
71205
Product ID
71205-767_e31a5901-ef04-4515-bca4-79118a3f3797
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204304
Marketing category
ANDA
Marketing start
2017-01-05
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
71205-767-30Finasteride30 in 1 BOTTLETABLET, FILM COATED301
71205-767-60Finasteride60 in 1 BOTTLETABLET, FILM COATED601
71205-767-90Finasteride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-767-30EA - Each71205-767213b30e7-bba7-4c7b-9427-9c85d829909012023-04-07
71205-767-90EA - Each71205-767bdf14813-7ac6-47f7-8c02-6a81f4ed9d3312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-767FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230306_e31a5901-ef04-4515-bca4-79118a3f3797.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNe31a5901-ef04-4515-bca4-79118a3f37971
310346finasteride 5 MG Oral TabletSCDe31a5901-ef04-4515-bca4-79118a3f37971
310346FIN5C 5 MG Oral TabletSYe31a5901-ef04-4515-bca4-79118a3f37971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-767-307120507673030 TABLET, FILM COATED in 1 BOTTLE (71205-767-30) 2023-02-23NoNoCurrent
71205-767-607120507676060 TABLET, FILM COATED in 1 BOTTLE (71205-767-60) 2023-02-23NoNoCurrent
71205-767-907120507679090 TABLET, FILM COATED in 1 BOTTLE (71205-767-90) 2023-02-23NoNoCurrent