Home NDC 80725-809 Jalyn
Product NDC 80725-809
11-digit product format 807250809
Labeler code 80725
Product ID 80725-809_bc6c62ea-da7b-4c27-a88e-c80cfcd7856d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Waylis Therapeutics
Application NDA022460
Marketing category NDA
Marketing start 2024-03-01
Substance DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Active strength .5; .4 mg/1; mg/1
Pharmacologic classes 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 80725-809-59 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 80725-809-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 80725-809-59 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 80725-809-13 f5e01cc5f278…a2eaf40c39c3…
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 N022460-001 JALYN DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB RLD 2010-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022460-001 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 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD 2010-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD 2010-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 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 Jalyn
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DUTASTERIDE .5 mg/1 TAMSULOSIN HYDROCHLORIDE .4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O0J6XJN02I Internal UNII lookup 11SV1951MR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996097 Internal RxNorm lookup 996101 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 80725-809-13 Jalyn 30 in 1 BOTTLE, PLASTIC CAPSULE 30 4 80725-809-59 Jalyn 90 in 1 BOTTLE, PLASTIC CAPSULE 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80725-809 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [WAYLIS THERAPEUTICS] 3 Current NDC, 2 package rows 20240719_aab9a2d4-5328-40f3-986f-e7753a928bc0.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Jalyn DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Waylis Therapeutics aab9a2d4-5328-40f3-986f-e7753a928bc0 2026-03-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 022460 application number: NDA022460 ndc (product): 80725-809
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80725-809-13 80725080913 30 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-13) 30 capsule 2024-03-01 No No Current 80725-809-59 80725080959 90 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-59) 90 capsule 2024-03-01 No No Current