Home NDC 16729-089 Finasteride
Product NDC 16729-089
11-digit product format 167290089
Labeler code 16729
Product ID 16729-089_2397604d-3fd8-2d97-e063-6394a90a0750
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Finasteride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Accord Healthcare, Inc.
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 16729-089-10 Finasteride 30 in 1 BOTTLE TABLET, FILM COATED 30 10 16729-089-15 Finasteride 90 in 1 BOTTLE TABLET, FILM COATED 90 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FINASTERIDE ACTIVE INGREDIENT 57GNO57U7G FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 FINASTERIDE ACTIVE MOIETY 57GNO57U7G FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 LAUROYL PEG-32 GLYCERIDES INACTIVE INGREDIENT H5ZC52369M FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-089 FINASTERIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241004_e3728709-e805-4b46-9954-2c433a865987.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 16729-089-10 16729008910 30 TABLET, FILM COATED in 1 BOTTLE (16729-089-10) 2013-11-08 0000-00-00 No No Current 16729-089-15 16729008915 90 TABLET, FILM COATED in 1 BOTTLE (16729-089-15) 2014-01-17 0000-00-00 No No Current