Home NDC 0173-0809-59 JALYN
Product NDC 0173-0809
Requested package NDC 0173-0809-59
11-digit product format 001730809
Labeler code 0173
Product ID 0173-0809_d4997425-dc8a-4f1d-9508-0fe326591fe9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dutasteride and tamsulosin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA022460
Marketing category NDA
Marketing start 2010-06-21
Marketing end 2024-03-31
Substance DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Active strength 1 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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DUTASTERIDE ACTIVE INGREDIENT O0J6XJN02I JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 TAMSULOSIN HYDROCHLORIDE ACTIVE INGREDIENT 11SV1951MR JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 DUTASTERIDE ACTIVE MOIETY O0J6XJN02I JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 TAMSULOSIN ACTIVE MOIETY G3P28OML5I JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 CAPRYLIC/CAPRIC MONO/DIGLYCERIDES INACTIVE INGREDIENT U72Q2I8C85 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 GELATIN INACTIVE INGREDIENT 2G86QN327L JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 TALC INACTIVE INGREDIENT 7SEV7J4R1U JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [GLAXOSMITHKLINE LLC] 14 DUTASTERIDE ACTIVE INGREDIENT O0J6XJN02I JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TAMSULOSIN HYDROCHLORIDE ACTIVE INGREDIENT 11SV1951MR JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 DUTASTERIDE ACTIVE MOIETY O0J6XJN02I JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TAMSULOSIN ACTIVE MOIETY G3P28OML5I JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CAPRYLIC/CAPRIC MONO/DIGLYCERIDES INACTIVE INGREDIENT U72Q2I8C85 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0173-0809-59 00173080959 90 CAPSULE in 1 BOTTLE (0173-0809-59) 90 capsule 2010-06-21 2024-03-31 No No Current