Home NDC 63187-863 Finasteride
Product NDC 63187-863
11-digit product format 631870863
Labeler code 63187
Product ID 63187-863_fdd2ba1f-49ae-46cb-8c9c-47d2b0d659ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Finasteride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA091643
Marketing category ANDA
Marketing start 2013-11-08
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091643-001 FINASTERIDE FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091643-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091643-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-11-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Finasteride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINASTERIDE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57GNO57U7G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200172 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63187-863-20 Finasteride 20 in 1 BOTTLE TABLET, FILM COATED 20 6 63187-863-30 Finasteride 30 in 1 BOTTLE TABLET, FILM COATED 30 6 63187-863-60 Finasteride 60 in 1 BOTTLE TABLET, FILM COATED 60 6 63187-863-90 Finasteride 90 in 1 BOTTLE TABLET, FILM COATED 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-863 FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] 6 Current NDC, Legacy NDC, 4 package rows 20220612_870ab7fe-fff9-4348-b900-213c1cf05f8e.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-863-20 63187086320 20 TABLET, FILM COATED in 1 BOTTLE (63187-863-20) 2022-02-11 0000-00-00 No No Current 63187-863-30 63187086330 30 TABLET, FILM COATED in 1 BOTTLE (63187-863-30) 2017-06-01 0000-00-00 No No Current 63187-863-60 63187086360 60 TABLET, FILM COATED in 1 BOTTLE (63187-863-60) 2017-06-01 0000-00-00 No No Current 63187-863-90 63187086390 90 TABLET, FILM COATED in 1 BOTTLE (63187-863-90) 2017-06-01 0000-00-00 No No Current