Finasteride

Product NDC
43598-303
11-digit product format
435980303
Labeler code
43598
Product ID
43598-303_8e1e332b-310c-a528-339a-702c542d14dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr Reddys Laboratories Inc
Application
ANDA090061
Marketing category
ANDA
Marketing start
2012-10-25
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
43598-303-30Finasteride30 in 1 BOTTLETABLET, FILM COATED305
43598-303-90Finasteride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-303-30EA - Each43598-303def81e29-b4f9-4638-9122-ad21090772ee12013-02-13
43598-303-90EA - Each43598-303d7c04aa7-5eba-44d7-b05d-7a44c12e3f0a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET [DR REDDYS LABORATORIES INC]2
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-303FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 2 package rows20241222_c8ed59a3-c5b2-3156-b781-5e514b79011b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNc8ed59a3-c5b2-3156-b781-5e514b79011b5
310346finasteride 5 MG Oral TabletSCDc8ed59a3-c5b2-3156-b781-5e514b79011b5
310346FIN5C 5 MG Oral TabletSYc8ed59a3-c5b2-3156-b781-5e514b79011b5
310346finasteride 5 MG Oral TabletPSNd089b70b-7961-488a-8f65-83038e1699831
310346finasteride 5 MG Oral TabletSCDd089b70b-7961-488a-8f65-83038e1699831
310346FIN5C 5 MG Oral TabletSYd089b70b-7961-488a-8f65-83038e1699831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-303-304359803033030 TABLET, FILM COATED in 1 BOTTLE (43598-303-30) 2012-10-250000-00-00NoNoCurrent
43598-303-904359803039090 TABLET, FILM COATED in 1 BOTTLE (43598-303-90) 2012-10-250000-00-00NoNoCurrent