Finasteride

Product NDC
70518-2287
11-digit product format
705182287
Labeler code
70518
Product ID
70518-2287_4e7db6c8-4f77-0460-e063-6394a90ab759
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207750
Marketing category
ANDA
Marketing start
2019-08-27
Substance
FINASTERIDE
Active strength
1 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-228770518-2287-1DDiscontinued by firm2026-08-11
excluded packagepackage70518-228770518-2287-2DDiscontinued by firm2026-08-11

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 · 23 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-2287-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2287-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-2287-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2287-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-2287-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170518-2287-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-2287-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870518-2287-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-2287-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170518-2287-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-2287-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070518-2287-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-2287-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170518-2287-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-2287-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-2287-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-2287-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-2287-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-2287-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870518-2287-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-2287-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0370518-2287-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-2287-1557ba5c1ecfa…9c80585c8c6e…

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
A207750-001FINASTERIDEFINASTERIDE1MGTABLET / ORALAB2017-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207750-001AB

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 UTC2026-02A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-063f01610625f2…
2019-09-15 20:21 UTC2019-09A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207750-001FINASTERIDE1MGTABLET / ORALAB2017-01-06cb3db0bc1861…

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 UTC2026-02A207750-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207750-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207750-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207750-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207750-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207750-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207750-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207750-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207750-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207750-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207750-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207750-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207750-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207750-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207750-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207750-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207750-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207750-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207750-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207750-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207750-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207750-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207750-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207750-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207750-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207750-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207750-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207750-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207750-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207750-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207750-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207750-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207750-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207750-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207750-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207750-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207750-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207750-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207750-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207750-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINASTERIDE1 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
200172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
90cc0d22-fa5c-4fe4-b0bf-554b715a05acAvailable 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
70518-2287-0Finasteride90 in 1 BOTTLE, PLASTICTABLET, COATED9012
70518-2287-1Finasteride30 in 1 BOTTLE, PLASTICTABLET, COATED3012
70518-2287-2Finasteride30 in 1 BLISTER PACKTABLET, COATED3012
70518-2287-3Finasteride12 in 1 BOTTLE, PLASTICTABLET, COATED1212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2287FINASTERIDE TABLET, COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 4 package rows20240911_90cc0d22-fa5c-4fe4-b0bf-554b715a05ac.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinasterideFINASTERIDEREMEDYREPACK INC.90cc0d22-fa5c-4fe4-b0bf-554b715a05ac2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750
ndc (product): 70518-2287
FinasterideFINASTERIDEA-S Medication Solutions49eb3a1e-d7e6-4652-aa6d-6abf21af34a62026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750
FinasterideFINASTERIDEPreferred Pharmaceuticals Inc.b84a67d6-695e-4a7c-9b60-95e9ad18a5012026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750
FinasterideFINASTERIDEAscend Laboratories, LLCecd2fbb2-a4bd-44f2-831d-179e7dbf07412025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750
FinasterideFINASTERIDENuCare Pharmaceuticals, Inc.291a2037-2b4f-a2fe-e063-6294a90a1e9a2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750
FinasterideFINASTERIDEBryant Ranch Prepack3e955ce4-d44e-4b4d-b763-ab141cb3f06d2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750
FinasterideFINASTERIDEProficient Rx LP196f7d23-ed90-46c2-ae34-615e6ec1650b2023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750
FinasterideFINASTERIDEThirty Madison Inc3fe7bdaa-b027-4da9-94ee-550bf28c63e12021-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207750
application number: ANDA207750

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN90cc0d22-fa5c-4fe4-b0bf-554b715a05ac12
200172finasteride 1 MG Oral TabletSCD90cc0d22-fa5c-4fe4-b0bf-554b715a05ac12
200172FIN5C 1 MG Oral TabletSY90cc0d22-fa5c-4fe4-b0bf-554b715a05ac12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2287-07051822870090 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2287-0) 2019-08-270000-00-00NoNoCurrent
70518-2287-17051822870130 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2287-1) 2022-02-140000-00-00NoNoCurrent
70518-2287-27051822870230 in 1 BLISTER PACKHistorical
70518-2287-37051822870312 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2287-3) 2026-04-02NoNoCurrent
70518-2287-47051822870430 POUCH in 1 BOX (70518-2287-4) / 1 TABLET, COATED in 1 POUCH (70518-2287-5)30 pouch2026-06-090Current
70518-2287-67051822870650 POUCH in 1 BOX (70518-2287-6) / 1 TABLET, COATED in 1 POUCH (70518-2287-5)50 pouch2026-07-090Current