Finasteride

Product NDC
57237-062
11-digit product format
572370062
Labeler code
57237
Product ID
57237-062_c44c39d5-9ec1-4714-838b-b03b69494caf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078341
Marketing category
ANDA
Marketing start
2007-10-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078341-001FINASTERIDEFINASTERIDE5MGTABLET / ORALAB2007-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078341-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078341-001FINASTERIDE5MGTABLET / ORALAB2007-10-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078341-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078341-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078341-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078341-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078341-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078341-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078341-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078341-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078341-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078341-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078341-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078341-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078341-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078341-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078341-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078341-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078341-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078341-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078341-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078341-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078341-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078341-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078341-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078341-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078341-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078341-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078341-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078341-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078341-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078341-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078341-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078341-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078341-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078341-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078341-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078341-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078341-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078341-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078341-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078341-001AB1cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57GNO57U7GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9cb6a9f1-f7a6-46be-9b2b-8f228c821b4dAvailable on FDA.report

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
57237-062-05Finasteride500 in 1 BOTTLETABLET, FILM COATED50011
57237-062-30Finasteride30 in 1 BOTTLETABLET, FILM COATED3011
57237-062-90Finasteride90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-062-05EA - Each57237-062576f4396-35a7-45b2-9660-f8c0747ac56d12016-05-16
57237-062-30EA - Each57237-062a4b8d8d7-1b4c-43dc-bf0d-8c61036b577112016-05-16
57237-062-90EA - Each57237-06211940c28-f784-4b79-90f7-97f1fddf83dc12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-062FINASTERIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]11Current NDC, Legacy NDC, 3 package rows20240303_9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinasterideFINASTERIDEREMEDYREPACK INC.da4e8a51-cf1c-4018-976f-edecc4934a392026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDEREMEDYREPACK INC.e482a50d-db15-4407-85c9-160c88e8a6572026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDEBryant Ranch Prepackc9a3cb34-9a8e-4538-ab90-32e08d8acc3a2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDEAurobindo Pharma Limited32266029-c710-44dd-943f-7e31d0afa6222026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDECoupler LLC5087f6f2-92c0-3feb-e063-6394a90ab17d2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDEPreferred Pharmaceuticals Inc.cdde1382-a995-4f53-9497-7724d5e25b662026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDENuCare Pharmaceuticals, Inc.2c688ec5-1b0f-2269-e063-6394a90a72202025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDENuCare Pharmaceuticals,Inc.6360d8cc-72df-c571-e053-2991aa0a72c52025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDENuCare Pharmaceuticals,Inc.fc9c4996-302c-2ad8-e053-6294a90a5f382025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDEAmerican Health Packaging8f468081-254a-4f11-9f0b-c0311e353a502024-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDEBryant Ranch Prepack61e6cbb8-ddd2-4e07-b182-6348f216858b2024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDEQUALLENT PHARMACEUTICALS HEALTH LLC5efc695c-d9fd-4892-a63f-a35cceb8d3c72024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
FinasterideFINASTERIDERising Pharma Holdings, Inc.9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d2024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341
ndc (product): 57237-062
FinasterideFINASTERIDEAsclemed USA, Inc.bafe8674-b7ee-47b2-94c1-842164ca6fa12021-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078341
application number: ANDA078341

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d11
310346finasteride 5 MG Oral TabletSCD9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d11
310346FIN5C 5 MG Oral TabletSY9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d11
310346finasteride 5 MG Oral TabletPSNda4e8a51-cf1c-4018-976f-edecc4934a3910
310346finasteride 5 MG Oral TabletSCDda4e8a51-cf1c-4018-976f-edecc4934a3910
310346FIN5C 5 MG Oral TabletSYda4e8a51-cf1c-4018-976f-edecc4934a3910
310346finasteride 5 MG Oral TabletPSN518c0b9e-331a-0a48-e054-00144ff8d46c4
310346finasteride 5 MG Oral TabletSCD518c0b9e-331a-0a48-e054-00144ff8d46c4
310346FIN5C 5 MG Oral TabletSY518c0b9e-331a-0a48-e054-00144ff8d46c4
310346finasteride 5 MG Oral TabletPSN61e6cbb8-ddd2-4e07-b182-6348f216858b3
310346finasteride 5 MG Oral TabletSCD61e6cbb8-ddd2-4e07-b182-6348f216858b3
310346FIN5C 5 MG Oral TabletSY61e6cbb8-ddd2-4e07-b182-6348f216858b3
310346finasteride 5 MG Oral TabletPSNbafe8674-b7ee-47b2-94c1-842164ca6fa11
310346finasteride 5 MG Oral TabletSCDbafe8674-b7ee-47b2-94c1-842164ca6fa11
310346FIN5C 5 MG Oral TabletSYbafe8674-b7ee-47b2-94c1-842164ca6fa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-062-0557237006205500 TABLET, FILM COATED in 1 BOTTLE (57237-062-05) 2007-10-300000-00-00NoNoCurrent
57237-062-305723700623030 TABLET, FILM COATED in 1 BOTTLE (57237-062-30) 2007-10-300000-00-00NoNoCurrent
57237-062-905723700629090 TABLET, FILM COATED in 1 BOTTLE (57237-062-90) 2007-10-300000-00-00NoNoCurrent