FDA.reportPublic FDA data

Finasteride

Product NDC
67877-288
11-digit product format
678770288
Labeler code
67877
Product ID
67877-288_7833df1e-7782-4e79-8b38-1eabcf8fd836
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67877-288-012020-02-03C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-052020-02-03C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-102020-02-03C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-302020-02-03C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-902020-02-03C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-012020-01-31C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-052020-01-31C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-102020-01-31C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-302020-01-31C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
67877-288-902020-01-31C16284748780-19d75b9cf-fe78-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-288-01Finasteride100 in 1 BOTTLETABLET, FILM COATED10023
67877-288-05Finasteride500 in 1 BOTTLETABLET, FILM COATED50023
67877-288-10Finasteride1000 in 1 BOTTLETABLET, FILM COATED100023
67877-288-30Finasteride30 in 1 BOTTLETABLET, FILM COATED3023
67877-288-33Finasteride10 in 1 BLISTER PACKTABLET, FILM COATED1023
67877-288-33Finasteride1 in 1 CARTONTABLET, FILM COATED123
67877-288-90Finasteride90 in 1 BOTTLETABLET, FILM COATED9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-288-01EA - Each67877-288a95bba02-1c3f-492d-ae40-ef1b441b88af12017-08-11
67877-288-05EA - Each67877-288ad8fdb98-8c7c-4beb-8c51-f1c3328bbf1e12017-03-06
67877-288-10EA - Each67877-2883b36cdb9-417f-4033-afc2-65b40e1ce13812017-12-14
67877-288-30EA - Each67877-288c6e8f66b-b6ba-49bb-b7a4-e3397a95674d12017-05-04
67877-288-90EA - Each67877-2888fb1d7f6-5db2-486b-b96d-07e128e1a59c12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-288FINASTERIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]22Current NDC, Legacy NDC, 7 package rows20240420_9b38c8c7-01e4-45d0-b4ee-3546d9ad849c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNa7a3af01-de3f-4cd4-ba05-a41ca0544ac2105
310346finasteride 5 MG Oral TabletSCDa7a3af01-de3f-4cd4-ba05-a41ca0544ac2105
310346FIN5C 5 MG Oral TabletSYa7a3af01-de3f-4cd4-ba05-a41ca0544ac2105
310346finasteride 5 MG Oral TabletPSN9b38c8c7-01e4-45d0-b4ee-3546d9ad849c23
310346finasteride 5 MG Oral TabletSCD9b38c8c7-01e4-45d0-b4ee-3546d9ad849c23
310346FIN5C 5 MG Oral TabletSY9b38c8c7-01e4-45d0-b4ee-3546d9ad849c23
310346finasteride 5 MG Oral TabletPSNaa3fcd1a-02a1-49db-b40e-75e623d730e19
310346finasteride 5 MG Oral TabletSCDaa3fcd1a-02a1-49db-b40e-75e623d730e19
310346FIN5C 5 MG Oral TabletSYaa3fcd1a-02a1-49db-b40e-75e623d730e19
310346finasteride 5 MG Oral TabletPSN5e69ea84-dc5a-4aac-9353-4920c6f7b3aa8
310346finasteride 5 MG Oral TabletSCD5e69ea84-dc5a-4aac-9353-4920c6f7b3aa8
310346FIN5C 5 MG Oral TabletSY5e69ea84-dc5a-4aac-9353-4920c6f7b3aa8
310346finasteride 5 MG Oral TabletPSN845cad9c-c50d-4c98-8df8-893d1241836a2
310346finasteride 5 MG Oral TabletPSN33295dce-1e81-4187-bce1-d9b332ea062e2
310346finasteride 5 MG Oral TabletPSN13673a09-8a50-5cd0-e063-6294a90a3d5b2
310346finasteride 5 MG Oral TabletPSNfe7e6ea7-583e-22d4-e053-6394a90a25262
310346finasteride 5 MG Oral TabletSCDfe7e6ea7-583e-22d4-e053-6394a90a25262
310346finasteride 5 MG Oral TabletSCD845cad9c-c50d-4c98-8df8-893d1241836a2
310346finasteride 5 MG Oral TabletSCD33295dce-1e81-4187-bce1-d9b332ea062e2
310346finasteride 5 MG Oral TabletSCD13673a09-8a50-5cd0-e063-6294a90a3d5b2
310346FIN5C 5 MG Oral TabletSY845cad9c-c50d-4c98-8df8-893d1241836a2
310346FIN5C 5 MG Oral TabletSY33295dce-1e81-4187-bce1-d9b332ea062e2
310346FIN5C 5 MG Oral TabletSYfe7e6ea7-583e-22d4-e053-6394a90a25262
310346FIN5C 5 MG Oral TabletSY13673a09-8a50-5cd0-e063-6294a90a3d5b2
310346finasteride 5 MG Oral TabletPSNe31a5901-ef04-4515-bca4-79118a3f37971
310346finasteride 5 MG Oral TabletPSNe6ee2f07-63a6-4fde-88de-654bf633529e1
310346finasteride 5 MG Oral TabletSCDe31a5901-ef04-4515-bca4-79118a3f37971
310346finasteride 5 MG Oral TabletSCDe6ee2f07-63a6-4fde-88de-654bf633529e1
310346FIN5C 5 MG Oral TabletSYe31a5901-ef04-4515-bca4-79118a3f37971
310346FIN5C 5 MG Oral TabletSYe6ee2f07-63a6-4fde-88de-654bf633529e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-288-0167877028801100 TABLET, FILM COATED in 1 BOTTLE (67877-288-01) 2017-01-050000-00-00NoNoCurrent
67877-288-0567877028805500 TABLET, FILM COATED in 1 BOTTLE (67877-288-05) 2017-01-050000-00-00NoNoCurrent
67877-288-10678770288101000 TABLET, FILM COATED in 1 BOTTLE (67877-288-10) 2017-01-050000-00-00NoNoCurrent
67877-288-306787702883030 TABLET, FILM COATED in 1 BOTTLE (67877-288-30) 2017-01-050000-00-00NoNoCurrent
67877-288-33678770288331 BLISTER PACK in 1 CARTON (67877-288-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-11-300000-00-00NoNoCurrent
67877-288-906787702889090 TABLET, FILM COATED in 1 BOTTLE (67877-288-90) 2017-01-050000-00-00NoNoCurrent