Home NDC 78206-153 PROSCAR
Product NDC 78206-153
11-digit product format 782060153
Labeler code 78206
Product ID 78206-153_979b0a0c-7868-4ec1-8887-f2b7e43f4326
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FINASTERIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Organon LLC
Application NDA020180
Marketing category NDA
Marketing start 2021-06-01
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020180-001 PROSCAR FINASTERIDE 5MG TABLET / ORAL AB RLD, RS 1992-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020180-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020180-001 PROSCAR 5MG TABLET / ORAL AB RLD, RS 1992-06-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PROSCAR
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 201961 Internal RxNorm lookup 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 78206-153-01 PROSCAR 30 in 1 BOTTLE TABLET, FILM COATED 30 9 78206-153-02 PROSCAR 100 in 1 BOTTLE TABLET, FILM COATED 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-153 PROSCAR (FINASTERIDE) TABLET, FILM COATED [ORGANON LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241225_6f988153-fc74-4ca4-b29a-111f750c4a4b.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 · 1 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 78206-153-01 78206015301 30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01) 2021-06-01 0000-00-00 No No Current 78206-153-02 78206015302 100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02) 2021-06-01 0000-00-00 No No Current