FDA.reportPublic FDA data

Finasteride

Product NDC
31722-525
11-digit product format
317220525
Labeler code
31722
Product ID
31722-525_2c74278f-8221-8804-e063-6394a90a7eaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA090061
Marketing category
ANDA
Marketing start
2015-06-13
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
31722-525-01Finasteride100 in 1 BOTTLETABLET, FILM COATED10010
31722-525-05Finasteride500 in 1 BOTTLETABLET, FILM COATED50010
31722-525-10Finasteride1000 in 1 BOTTLETABLET, FILM COATED100010
31722-525-30Finasteride30 in 1 BOTTLETABLET, FILM COATED3010
31722-525-30Finasteride12 in 1 CASETABLET, FILM COATED1210
31722-525-90Finasteride90 in 1 BOTTLETABLET, FILM COATED9010
31722-525-90Finasteride12 in 1 CASETABLET, FILM COATED1210
31722-525-01Finasteride100 in 1 BOTTLETABLET, FILM COATED1004
31722-525-05Finasteride500 in 1 BOTTLETABLET, FILM COATED5004
31722-525-10Finasteride1000 in 1 BOTTLETABLET, FILM COATED10004
31722-525-30Finasteride12 in 1 CASETABLET, FILM COATED124
31722-525-30Finasteride30 in 1 BOTTLETABLET, FILM COATED304
31722-525-90Finasteride12 in 1 CASETABLET, FILM COATED124
31722-525-90Finasteride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-525-01EA - Each31722-5252dff9b3e-ca6d-452d-8f3f-a89fd6f1519d12012-07-24
31722-525-10EA - Each31722-52543ebfb38-bbff-4dbc-a940-c85be46e8cb412013-09-04
31722-525-30EA - Each31722-525c2793c4d-dc59-4fbc-a265-ec6351261ded12012-07-24
31722-525-90EA - Each31722-525dbdcf86e-ce15-44f3-bca7-8878f44bd22712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-525FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 7 package rows20250125_cc9709ce-2d29-48bd-b46b-3f72114f2527.zip
31722-525FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 7 package rows20110111_c59f8018-fff8-4884-a3c8-bc306e2c8f64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN2d726486-f9ef-49d1-b1ae-6b1c8650fa7316
310346finasteride 5 MG Oral TabletSCD2d726486-f9ef-49d1-b1ae-6b1c8650fa7316
310346FIN5C 5 MG Oral TabletSY2d726486-f9ef-49d1-b1ae-6b1c8650fa7316
310346finasteride 5 MG Oral TabletPSNcc9709ce-2d29-48bd-b46b-3f72114f252710
310346finasteride 5 MG Oral TabletPSNa3b49681-09b3-4c26-bb57-3dfd598d48b610
310346finasteride 5 MG Oral TabletSCDcc9709ce-2d29-48bd-b46b-3f72114f252710
310346finasteride 5 MG Oral TabletSCDa3b49681-09b3-4c26-bb57-3dfd598d48b610
310346FIN5C 5 MG Oral TabletSYcc9709ce-2d29-48bd-b46b-3f72114f252710
310346FIN5C 5 MG Oral TabletSYa3b49681-09b3-4c26-bb57-3dfd598d48b610
310346finasteride 5 MG Oral TabletPSNc2875bc7-e811-4860-9131-da06cecc21378
310346finasteride 5 MG Oral TabletSCDc2875bc7-e811-4860-9131-da06cecc21378
310346FIN5C 5 MG Oral TabletSYc2875bc7-e811-4860-9131-da06cecc21378
310346finasteride 5 MG Oral TabletPSN3272651f-b500-4d5d-9e29-22fcd8e24fcb7
310346finasteride 5 MG Oral TabletSCD3272651f-b500-4d5d-9e29-22fcd8e24fcb7
310346FIN5C 5 MG Oral TabletSY3272651f-b500-4d5d-9e29-22fcd8e24fcb7
310346finasteride 5 MG Oral TabletPSN9ae38bf5-17d7-4af1-922f-b3edb1e653925
310346finasteride 5 MG Oral TabletPSN800fa54c-c008-ba1e-e053-2a91aa0a2b075
310346finasteride 5 MG Oral TabletSCD800fa54c-c008-ba1e-e053-2a91aa0a2b075
310346finasteride 5 MG Oral TabletSCD9ae38bf5-17d7-4af1-922f-b3edb1e653925
310346FIN5C 5 MG Oral TabletSY800fa54c-c008-ba1e-e053-2a91aa0a2b075
310346FIN5C 5 MG Oral TabletSY9ae38bf5-17d7-4af1-922f-b3edb1e653925
310346finasteride 5 MG Oral TabletPSNc59f8018-fff8-4884-a3c8-bc306e2c8f644
310346finasteride 5 MG Oral TabletSCDc59f8018-fff8-4884-a3c8-bc306e2c8f644
310346FIN5C 5 MG Oral TabletSYc59f8018-fff8-4884-a3c8-bc306e2c8f644
310346finasteride 5 MG Oral TabletPSNd66fe4bd-534b-4674-a346-0cf3cdabbfaa1
310346finasteride 5 MG Oral TabletPSNdee6b60d-3b6c-35a4-e053-2995a90acf561
310346finasteride 5 MG Oral TabletSCDd66fe4bd-534b-4674-a346-0cf3cdabbfaa1
310346finasteride 5 MG Oral TabletSCDdee6b60d-3b6c-35a4-e053-2995a90acf561
310346FIN5C 5 MG Oral TabletSYd66fe4bd-534b-4674-a346-0cf3cdabbfaa1
310346FIN5C 5 MG Oral TabletSYdee6b60d-3b6c-35a4-e053-2995a90acf561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-525-0131722052501100 TABLET, FILM COATED in 1 BOTTLE (31722-525-01) 2015-06-130000-00-00NoNoCurrent
31722-525-0531722052505500 TABLET, FILM COATED in 1 BOTTLE (31722-525-05) 2015-06-130000-00-00NoNoCurrent
31722-525-10317220525101000 TABLET, FILM COATED in 1 BOTTLE (31722-525-10) 2015-06-130000-00-00NoNoCurrent
31722-525-303172205253012 BOTTLE in 1 CASE (31722-525-30) / 30 TABLET, FILM COATED in 1 BOTTLE12 bottle2015-06-130000-00-00NoNoCurrent
31722-525-903172205259012 BOTTLE in 1 CASE (31722-525-90) / 90 TABLET, FILM COATED in 1 BOTTLE12 bottle2015-06-130000-00-00NoNoCurrent