Home NDC 0615-8562 Finasteride
Product NDC 0615-8562
11-digit product format 006158562
Labeler code 0615
Product ID 0615-8562_4e1dfb0e-d523-48d2-8c82-c80ee2b49800
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Finasteride
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA076437
Marketing category ANDA
Marketing start 2007-02-28
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 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 A076437-001 FINASTERIDE FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076437-001 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 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076437-001 FINASTERIDE 5MG TABLET / ORAL AB 2007-02-28 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 5 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 310346 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 0615-8562-05 Finasteride 15 in 1 BLISTER PACK TABLET 15 1 0615-8562-39 Finasteride 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8562 FINASTERIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 1 Current NDC, 2 package rows 20250302_8c3b1f6b-0010-4432-8eda-4af3c3573063.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 Units Marketing start Sample Exclude flag Status 0615-8562-05 00615856205 15 TABLET in 1 BLISTER PACK (0615-8562-05) 15 tablet 2025-02-11 No No Current 0615-8562-39 00615856239 30 TABLET in 1 BLISTER PACK (0615-8562-39) 30 tablet 2025-02-11 No No Current