Finasteride

Product NDC
76282-412
11-digit product format
762820412
Labeler code
76282
Product ID
76282-412_6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA090061
Marketing category
ANDA
Marketing start
2015-05-22
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 42.

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
A090061-001FINASTERIDEFINASTERIDE5MGTABLET / ORALAB2010-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090061-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073f01610625f2…
2019-09-15 20:21 UTC2019-09A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090061-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090061-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090061-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090061-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090061-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090061-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090061-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090061-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090061-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090061-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090061-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090061-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090061-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090061-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090061-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090061-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090061-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090061-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090061-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090061-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090061-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090061-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090061-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090061-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090061-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090061-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090061-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090061-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090061-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090061-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090061-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090061-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090061-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090061-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090061-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090061-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090061-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090061-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090061-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090061-001AB1e64feba35796…

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
1c1bf77c-f99a-44e4-b71e-ce766afa99b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
76282-412-05Finasteride500 in 1 BOTTLETABLET, FILM COATED5006
76282-412-10Finasteride1000 in 1 BOTTLETABLET, FILM COATED10006
76282-412-30Finasteride30 in 1 BOTTLETABLET, FILM COATED306
76282-412-90Finasteride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-412-05EA - Each76282-412a32c976e-d916-4a2c-bd20-8a386ac31a7512013-11-04
76282-412-30EA - Each76282-412d261e7f3-76ca-433e-87be-efb19022fb5112013-11-04
76282-412-90EA - Each76282-41262d5a9de-3f55-4419-8f6e-2ede91543e6612013-11-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-412FINASTERIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20201104_1c1bf77c-f99a-44e4-b71e-ce766afa99b6.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinasterideFINASTERIDECardinal Health 107, LLC3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd042026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDECardinal Health 107, LLC22161236-6804-4a7f-86cb-cfa20bd1951e2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEPreferred Pharmaceuticals, Inc.9ae38bf5-17d7-4af1-922f-b3edb1e653922026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEREMEDYREPACK INC.c2875bc7-e811-4860-9131-da06cecc21372026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDELegacy Pharmaceutical Packaging, LLCa3b49681-09b3-4c26-bb57-3dfd598d48b62026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEA-S Medication Solutions2d726486-f9ef-49d1-b1ae-6b1c8650fa732026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEAvPAK800fa54c-c008-ba1e-e053-2a91aa0a2b072026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEMajor Pharmaceuticals3272651f-b500-4d5d-9e29-22fcd8e24fcb2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDECamber Pharmaceuticals, Inc.cc9709ce-2d29-48bd-b46b-3f72114f25272025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEDr Reddys Laboratories Incc8ed59a3-c5b2-3156-b781-5e514b79011b2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEA-S Medication Solutionsd66fe4bd-534b-4674-a346-0cf3cdabbfaa2024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEAphena Pharma Solutions - Tennessee, LLC57e73fff-2115-41ad-864b-4652f9fd45452024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
FinasterideFINASTERIDEExelan Pharmaceuticals Inc.1c1bf77c-f99a-44e4-b71e-ce766afa99b62020-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
ndc (product): 76282-412

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310346finasteride 5 MG Oral TabletPSN1c1bf77c-f99a-44e4-b71e-ce766afa99b66
310346finasteride 5 MG Oral TabletSCD1c1bf77c-f99a-44e4-b71e-ce766afa99b66
310346FIN5C 5 MG Oral TabletSY1c1bf77c-f99a-44e4-b71e-ce766afa99b66
310346finasteride 5 MG Oral TabletPSN57e73fff-2115-41ad-864b-4652f9fd45452
310346finasteride 5 MG Oral TabletSCD57e73fff-2115-41ad-864b-4652f9fd45452
310346FIN5C 5 MG Oral TabletSY57e73fff-2115-41ad-864b-4652f9fd45452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-412-0576282041205500 TABLET, FILM COATED in 1 BOTTLE (76282-412-05) 2015-05-220000-00-00NoNoCurrent
76282-412-10762820412101000 TABLET, FILM COATED in 1 BOTTLE (76282-412-10) 2015-05-220000-00-00NoNoCurrent
76282-412-307628204123030 TABLET, FILM COATED in 1 BOTTLE (76282-412-30) 2015-05-220000-00-00NoNoCurrent
76282-412-907628204129090 TABLET, FILM COATED in 1 BOTTLE (76282-412-90) 2015-05-220000-00-00NoNoCurrent