JALYN

Product NDC: 0173-0809
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0173-0809		D	Discontinued by firm	2026-08-11
excluded package	package	0173-0809	0173-0809-13	D	Discontinued by firm	2026-08-11
excluded package	package	0173-0809	0173-0809-59	D	Discontinued by firm	2026-08-11

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 · 36 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	0173-0809-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0173-0809-59	`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	0173-0809-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0173-0809-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0173-0809-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0173-0809-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0173-0809-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0173-0809-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0173-0809-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0173-0809-59	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0173-0809-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0173-0809-59	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0173-0809-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0173-0809-59	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0173-0809-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0173-0809-59	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0173-0809-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0173-0809-59	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0173-0809-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0173-0809-59	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0173-0809-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0173-0809-59	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0173-0809-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0173-0809-59	`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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022460-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022460-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022460-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022460-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022460-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022460-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022460-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022460-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022460-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022460-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022460-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022460-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022460-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022460-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022460-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022460-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022460-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022460-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022460-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022460-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022460-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022460-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022460-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022460-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022460-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022460-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022460-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022460-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022460-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022460-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022460-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022460-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022460-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022460-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022460-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022460-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022460-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022460-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022460-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022460-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
ee39297f-c54b-4394-13fa-e0de7b5b9070	Product name	4	20250305
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
ae349df8-97ce-a639-ed32-50a4cb01b1bd	Product name	4	20200313
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
15cfa3ee-23c6-c9fd-f216-95d9676ee575	Product name	9	20180814
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0173-0809-13	2020-09-01	These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN. JALYN (dutasteride and tamsulosin hydrochloride) capsules Initial U.S. Approval: 2010
0173-0809-59	2020-09-01	These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN. JALYN (dutasteride and tamsulosin hydrochloride) capsules Initial U.S. Approval: 2010
0173-0809-13	2020-07-22	These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN. JALYN (dutasteride and tamsulosin hydrochloride) capsules Initial U.S. Approval: 2010
0173-0809-59	2020-07-22	These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN. JALYN (dutasteride and tamsulosin hydrochloride) capsules Initial U.S. Approval: 2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0809-13	EA - Each	0173-0809	9d2d062f-0d64-4cf0-bad4-fc7a13714512	1	2012-07-24
0173-0809-59	EA - Each	0173-0809	aad0be62-4246-4beb-b008-64981fbde5c1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O0J6XJN02I	DUTASTERIDE	164656-23-9	DUTASTERIDE
11SV1951MR	TAMSULOSIN HYDROCHLORIDE	106463-17-6	TAMSULOSIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996097	dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral Capsule	PSN	f96c6acd-4d02-4ece-bd54-2d5a35aab7f5	1
996101	Jalyn 0.5 MG / 0.4 MG Oral Capsule	PSN	f96c6acd-4d02-4ece-bd54-2d5a35aab7f5	1
996101	dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]	SBD	f96c6acd-4d02-4ece-bd54-2d5a35aab7f5	1
996097	dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	f96c6acd-4d02-4ece-bd54-2d5a35aab7f5	1
996101	Jalyn (dutasteride 0.5 MG / tamsulosin HCl 0.4 MG) Oral Capsule	SY	f96c6acd-4d02-4ece-bd54-2d5a35aab7f5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0809-13	00173080913	30 CAPSULE in 1 BOTTLE (0173-0809-13)	30 capsule	2010-06-21	0000-00-00	No	No	Current
0173-0809-59	00173080959	90 CAPSULE in 1 BOTTLE (0173-0809-59)	90 capsule	2010-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
JALYN	GlaxoSmithKline LLC	2020-12-29	HUMAN PRESCRIPTION DRUG LABEL	21
JALYN	Physicians Total Care, Inc.	2012-05-16	HUMAN PRESCRIPTION DRUG LABEL	1