Finasteride

Product NDC
65862-927
11-digit product format
658620927
Labeler code
65862
Product ID
65862-927_92ac09b3-d036-4c90-81e6-c13310f0a673
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203687
Marketing category
ANDA
Marketing start
2014-09-20
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
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
A203687-001FINASTERIDEFINASTERIDE1MGTABLET / ORALAB2013-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203687-001AB

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 UTC2026-02A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-053f01610625f2…
2019-09-15 20:21 UTC2019-09A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203687-001FINASTERIDE1MGTABLET / ORALAB2013-11-05cb3db0bc1861…

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 UTC2026-02A203687-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203687-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203687-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203687-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203687-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203687-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203687-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203687-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203687-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203687-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203687-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203687-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203687-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203687-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203687-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203687-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203687-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203687-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203687-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203687-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203687-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203687-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203687-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203687-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203687-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203687-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203687-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203687-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203687-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203687-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203687-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203687-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203687-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203687-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203687-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203687-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203687-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203687-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203687-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203687-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride
Listing expiration
2026-12-31

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
7d140366-2388-488e-bd86-67e6edf44345Available 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
65862-927-30Finasteride30 in 1 BOTTLETABLET, FILM COATED3013
65862-927-90Finasteride90 in 1 BOTTLETABLET, FILM COATED9013
65862-927-99Finasteride1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-927-30EA - Each65862-927e59380f4-7849-4149-a118-2d3aa7ad413912014-11-05
65862-927-90EA - Each65862-9275174ee75-e742-453b-95b0-0f8f938a385012014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINASTERIDEACTIVE INGREDIENT57GNO57U7GFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FINASTERIDEACTIVE MOIETY57GNO57U7GFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
TALCINACTIVE INGREDIENT7SEV7J4R1UFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-927FINASTERIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 3 package rows20240426_7d140366-2388-488e-bd86-67e6edf44345.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.03429cec-c6b5-47fe-bb11-6b42f977df7e2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687
FinasterideFINASTERIDENuCare Pharmaceuticals, Inc.51286a03-c29c-2c0b-e063-6394a90af33c2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687
FinasterideFINASTERIDEPreferred Pharmaceuticals Inc.74b90430-8ce1-470c-939c-685ca9dfd74f2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687
FinasterideFINASTERIDENuCare Pharmaceuticals,Inc.8488cd17-365c-701c-e053-2991aa0af5f92024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687
FinasterideFINASTERIDEBurel Pharmaceuticals, LLCc8516eaa-98d0-4eb1-bc65-aa765baea5db2024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687
FinasterideFINASTERIDERising Pharma Holdings, Inc.01b88593-99d3-4dd6-a7b6-5438c15bd7b72024-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687
FinasterideFINASTERIDEAurobindo Pharma Limited7d140366-2388-488e-bd86-67e6edf443452024-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687
ndc (product): 65862-927
FinasterideFINASTERIDEAsclemed USA, Inc.b2cac9e5-ea52-44b7-ae88-78e11a7329042022-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203687
application number: ANDA203687

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN7d140366-2388-488e-bd86-67e6edf4434513
200172finasteride 1 MG Oral TabletSCD7d140366-2388-488e-bd86-67e6edf4434513
200172FIN5C 1 MG Oral TabletSY7d140366-2388-488e-bd86-67e6edf4434513
200172finasteride 1 MG Oral TabletPSN74b90430-8ce1-470c-939c-685ca9dfd74f11
200172finasteride 1 MG Oral TabletSCD74b90430-8ce1-470c-939c-685ca9dfd74f11
200172FIN5C 1 MG Oral TabletSY74b90430-8ce1-470c-939c-685ca9dfd74f11
200172finasteride 1 MG Oral TabletPSN8488cd17-365c-701c-e053-2991aa0af5f93
200172finasteride 1 MG Oral TabletSCD8488cd17-365c-701c-e053-2991aa0af5f93
200172FIN5C 1 MG Oral TabletSY8488cd17-365c-701c-e053-2991aa0af5f93
200172finasteride 1 MG Oral TabletPSNf477dc5b-1c53-4866-bcba-8e26b2873a2b2
200172finasteride 1 MG Oral TabletSCDf477dc5b-1c53-4866-bcba-8e26b2873a2b2
200172FIN5C 1 MG Oral TabletSYf477dc5b-1c53-4866-bcba-8e26b2873a2b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-927-306586209273030 TABLET, FILM COATED in 1 BOTTLE (65862-927-30) 2014-09-200000-00-00NoNoCurrent
65862-927-906586209279090 TABLET, FILM COATED in 1 BOTTLE (65862-927-90) 2014-09-200000-00-00NoNoCurrent
65862-927-99658620927991000 TABLET, FILM COATED in 1 BOTTLE (65862-927-99) 2014-09-200000-00-00NoNoCurrent