Finasteride

Product NDC
68071-1648
11-digit product format
680711648
Labeler code
68071
Product ID
68071-1648_518c0b9e-331b-0a48-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078341
Marketing category
ANDA
Marketing start
2007-10-30
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-1648IInactivated by FDA2026-08-07
excluded packagepackage68071-164868071-1648-9IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-1648-9IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-1648-9IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-1648-9IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-1648-9IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-1648-9IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-1648-9IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-1648-9UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-1648-9UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-1648-9UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1648-9Finasteride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1648FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]4Legacy NDC, 1 package rows20230715_518c0b9e-331a-0a48-e054-00144ff8d46c.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
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 TabletPSN518c0b9e-331a-0a48-e054-00144ff8d46c4
310346finasteride 5 MG Oral TabletSCD518c0b9e-331a-0a48-e054-00144ff8d46c4
310346FIN5C 5 MG Oral TabletSY518c0b9e-331a-0a48-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68071-1648-96807116480990 in 1 BOTTLEHistorical