Finasteride

Product NDC
0093-7355
11-digit product format
000937355
Labeler code
0093
Product ID
0093-7355_c5126a52-1e69-447d-800f-ba863246b7d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076511
Marketing category
ANDA
Marketing start
2006-12-15
Marketing end
2026-09-30
Substance
FINASTERIDE
Active strength
5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride

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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
0093-7355-05Finasteride500 in 1 BOTTLETABLET, FILM COATED50021
0093-7355-56Finasteride30 in 1 BOTTLETABLET, FILM COATED3021
0093-7355-98Finasteride90 in 1 BOTTLETABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7355-05EA - Each0093-73555c6cc93b-def7-4a83-938b-675aab851e7d12012-07-24
0093-7355-56EA - Each0093-7355e1cad40e-b75f-49ed-b8b8-dbedaa5b134c12012-07-24
0093-7355-98EA - Each0093-7355b02f92d7-f46c-4b91-91c8-a622203c6eaa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7355FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 3 package rows20220304_77589cc3-c440-4695-800c-82a0e5128a6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN77589cc3-c440-4695-800c-82a0e5128a6c21
310346finasteride 5 MG Oral TabletSCD77589cc3-c440-4695-800c-82a0e5128a6c21
310346FIN5C 5 MG Oral TabletSY77589cc3-c440-4695-800c-82a0e5128a6c21
310346finasteride 5 MG Oral TabletPSN1e04fe02-88ac-dafd-e063-6294a90ac4c91
310346finasteride 5 MG Oral TabletSCD1e04fe02-88ac-dafd-e063-6294a90ac4c91
310346FIN5C 5 MG Oral TabletSY1e04fe02-88ac-dafd-e063-6294a90ac4c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7355-0500093735505500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05) 2008-03-142026-09-30NoNoCurrent
0093-7355-560009373555630 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56) 2006-12-152026-09-30NoNoCurrent
0093-7355-980009373559890 TABLET, FILM COATED in 1 BOTTLE (0093-7355-98) 2007-02-222026-09-30NoNoCurrent