FDA.reportPublic FDA data

Finasteride

Product NDC
55111-172
11-digit product format
551110172
Labeler code
55111
Product ID
55111-172_3e2181d6-f6be-c77e-e3f3-63e26fc35897
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076437
Marketing category
ANDA
Marketing start
2007-02-28
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
55111-172-01Finasteride100 in 1 BOTTLETABLET1007
55111-172-05Finasteride500 in 1 BOTTLETABLET5007
55111-172-30Finasteride30 in 1 BOTTLETABLET307
55111-172-78Finasteride10 in 1 CARTONTABLET107
55111-172-79Finasteride10 in 1 BLISTER PACKTABLET107
55111-172-90Finasteride90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-172-05EA - Each55111-1724209d7c7-316d-4c89-a3ec-2b475f4c514412025-11-13
55111-172-30EA - Each55111-172ab01af57-f6a7-43a0-992b-c0612e09533f12012-07-24
55111-172-90EA - Each55111-172da8d0d12-4c72-43d1-b127-f1ef0d0a8c6c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-172FINASTERIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7Current NDC, Legacy NDC, 6 package rows20231213_a4dd6d6c-c8c7-16a9-aa68-aa46283dfae1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSNa4dd6d6c-c8c7-16a9-aa68-aa46283dfae17
310346finasteride 5 MG Oral TabletSCDa4dd6d6c-c8c7-16a9-aa68-aa46283dfae17
310346FIN5C 5 MG Oral TabletSYa4dd6d6c-c8c7-16a9-aa68-aa46283dfae17
310346finasteride 5 MG Oral TabletPSN8c3b1f6b-0010-4432-8eda-4af3c35730631
310346finasteride 5 MG Oral TabletSCD8c3b1f6b-0010-4432-8eda-4af3c35730631
310346FIN5C 5 MG Oral TabletSY8c3b1f6b-0010-4432-8eda-4af3c35730631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-172-0155111017201100 TABLET in 1 BOTTLE (55111-172-01) 100 tablet2007-02-280000-00-00NoNoCurrent
55111-172-0555111017205500 TABLET in 1 BOTTLE (55111-172-05) 500 tablet2007-02-280000-00-00NoNoCurrent
55111-172-305511101723030 TABLET in 1 BOTTLE (55111-172-30) 30 tablet2007-02-280000-00-00NoNoCurrent
55111-172-785511101727810 BLISTER PACK in 1 CARTON (55111-172-78) / 10 TABLET in 1 BLISTER PACK (55111-172-79) 10 blister pack2007-02-280000-00-00NoNoCurrent
55111-172-795511101727910 in 1 BLISTER PACKHistorical
55111-172-905511101729090 TABLET in 1 BOTTLE (55111-172-90) 90 tablet2007-02-280000-00-00NoNoCurrent