PROSCAR

Product NDC
78206-153
11-digit product format
782060153
Labeler code
78206
Product ID
78206-153_979b0a0c-7868-4ec1-8887-f2b7e43f4326
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FINASTERIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Organon LLC
Application
NDA020180
Marketing category
NDA
Marketing start
2021-06-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROSCAR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINASTERIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57GNO57U7G
Rxcui201961, 310346

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
78206-153-01PROSCAR30 in 1 BOTTLETABLET, FILM COATED309
78206-153-02PROSCAR100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-153-01EA - Each78206-15347414e1a-8e96-40dd-bd8b-8f55cf351b3e12021-08-05
78206-153-02EA - Each78206-1530c87f33d-b4cf-483a-b4d1-f9ecbd1ede0012021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-153PROSCAR (FINASTERIDE) TABLET, FILM COATED [ORGANON LLC]8Current NDC, Legacy NDC, 2 package rows20241225_6f988153-fc74-4ca4-b29a-111f750c4a4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN6f988153-fc74-4ca4-b29a-111f750c4a4b9
201961Proscar 5 MG Oral TabletPSN6f988153-fc74-4ca4-b29a-111f750c4a4b9
201961finasteride 5 MG Oral Tablet [Proscar]SBD6f988153-fc74-4ca4-b29a-111f750c4a4b9
310346finasteride 5 MG Oral TabletSCD6f988153-fc74-4ca4-b29a-111f750c4a4b9
310346FIN5C 5 MG Oral TabletSY6f988153-fc74-4ca4-b29a-111f750c4a4b9
201961FIN5C 5 MG Oral Tablet [Proscar]SY6f988153-fc74-4ca4-b29a-111f750c4a4b9
201961Proscar 5 MG Oral TabletSY6f988153-fc74-4ca4-b29a-111f750c4a4b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78206-153-017820601530130 TABLET, FILM COATED in 1 BOTTLE (78206-153-01) 2021-06-010000-00-00NoNoCurrent
78206-153-0278206015302100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02) 2021-06-010000-00-00NoNoCurrent