Finasteride

Product NDC
67877-455
11-digit product format
678770455
Labeler code
67877
Product ID
67877-455_f4ed6589-2062-48b0-8a0c-25b0342342c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207750
Marketing category
ANDA
Marketing start
2017-01-06
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
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
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
ecd2fbb2-a4bd-44f2-831d-179e7dbf0741Available 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
67877-455-05Finasteride500 in 1 BOTTLETABLET, COATED50016
67877-455-30Finasteride30 in 1 BOTTLETABLET, COATED3016
67877-455-34Finasteride10 in 1 BLISTER PACKTABLET, COATED1016
67877-455-90Finasteride90 in 1 BOTTLETABLET, COATED9016
67877-455-94Finasteride3 in 1 CARTONTABLET, COATED316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-455-05EA - Each67877-455deb69016-78ea-45da-a41b-234079ced4eb12025-02-10
67877-455-30EA - Each67877-45560946042-ac11-4f5b-8c03-d73aea1a759412017-05-04
67877-455-90EA - Each67877-455740e41d8-9592-489b-9353-190d48ad545512017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-455FINASTERIDE TABLET, COATED [ASCEND LABORATORIES, LLC]16Current NDC, Legacy NDC, 5 package rows20250427_ecd2fbb2-a4bd-44f2-831d-179e7dbf0741.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
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
ndc (product): 67877-455
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 TabletPSNecd2fbb2-a4bd-44f2-831d-179e7dbf074116
200172finasteride 1 MG Oral TabletSCDecd2fbb2-a4bd-44f2-831d-179e7dbf074116
200172FIN5C 1 MG Oral TabletSYecd2fbb2-a4bd-44f2-831d-179e7dbf074116
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
200172finasteride 1 MG Oral TabletPSN49eb3a1e-d7e6-4652-aa6d-6abf21af34a610
200172finasteride 1 MG Oral TabletSCD49eb3a1e-d7e6-4652-aa6d-6abf21af34a610
200172FIN5C 1 MG Oral TabletSY49eb3a1e-d7e6-4652-aa6d-6abf21af34a610
200172finasteride 1 MG Oral TabletPSN3e955ce4-d44e-4b4d-b763-ab141cb3f06d7
200172finasteride 1 MG Oral TabletSCD3e955ce4-d44e-4b4d-b763-ab141cb3f06d7
200172FIN5C 1 MG Oral TabletSY3e955ce4-d44e-4b4d-b763-ab141cb3f06d7
200172finasteride 1 MG Oral TabletPSNb84a67d6-695e-4a7c-9b60-95e9ad18a5014
200172finasteride 1 MG Oral TabletSCDb84a67d6-695e-4a7c-9b60-95e9ad18a5014
200172FIN5C 1 MG Oral TabletSYb84a67d6-695e-4a7c-9b60-95e9ad18a5014
200172finasteride 1 MG Oral TabletPSN42c47e93-adad-47b5-8d5c-f0f3e26e74442
200172finasteride 1 MG Oral TabletPSN291a2037-2b4f-a2fe-e063-6294a90a1e9a2
200172finasteride 1 MG Oral TabletSCD42c47e93-adad-47b5-8d5c-f0f3e26e74442
200172finasteride 1 MG Oral TabletSCD291a2037-2b4f-a2fe-e063-6294a90a1e9a2
200172FIN5C 1 MG Oral TabletSY42c47e93-adad-47b5-8d5c-f0f3e26e74442
200172FIN5C 1 MG Oral TabletSY291a2037-2b4f-a2fe-e063-6294a90a1e9a2
200172finasteride 1 MG Oral TabletPSN196f7d23-ed90-46c2-ae34-615e6ec1650b1
200172finasteride 1 MG Oral TabletSCD196f7d23-ed90-46c2-ae34-615e6ec1650b1
200172FIN5C 1 MG Oral TabletSY196f7d23-ed90-46c2-ae34-615e6ec1650b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-455-0567877045505500 TABLET, COATED in 1 BOTTLE (67877-455-05) 2025-01-310000-00-00NoNoCurrent
67877-455-306787704553030 TABLET, COATED in 1 BOTTLE (67877-455-30) 2017-01-060000-00-00NoNoCurrent
67877-455-346787704553410 in 1 BLISTER PACKHistorical
67877-455-906787704559090 TABLET, COATED in 1 BOTTLE (67877-455-90) 2017-01-060000-00-00NoNoCurrent
67877-455-94678770455943 BLISTER PACK in 1 CARTON (67877-455-94) / 10 TABLET, COATED in 1 BLISTER PACK (67877-455-34) 3 blister pack2017-01-060000-00-00NoNoCurrent