Dutasteride and Tamsulosin Hydrochloride

Product NDC: 66993-580
11-digit product format: 669930580
Labeler code: 66993
Product ID: 66993-580_f5fa9102-81f2-47f0-9c32-79bf584413ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dutasteride and tamsulosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA022460
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-07-01
Marketing end: 2021-01-31
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	66993-580		D	Discontinued by firm	2026-08-11
excluded package	package	66993-580	66993-580-30	D	Discontinued by firm	2026-08-11
excluded package	package	66993-580	66993-580-85	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	66993-580-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66993-580-30	`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	66993-580-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66993-580-30	`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	66993-580-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66993-580-30	`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	66993-580-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66993-580-30	`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	66993-580-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66993-580-30	`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	66993-580-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66993-580-30	`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	66993-580-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66993-580-30	`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	66993-580-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66993-580-30	`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	66993-580-85	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-580-30	`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	66993-580-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66993-580-30	`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	66993-580-85	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66993-580-30	`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	66993-580-85	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66993-580-30	`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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-580-30	EA - Each	66993-580	9fc27649-c629-4751-a0e8-b12826f52929	1	2016-09-02
66993-580-85	EA - Each	66993-580	62dd05fd-c182-4a7e-9cf5-78f9866493ac	1	2016-09-02

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dutasteride and Tamsulosin Hydrochloride	Prasco Laboratories \| GlaxoSmithKline LLC	2018-02-12	HUMAN PRESCRIPTION DRUG LABEL	9