Dutasteride and Tamsulosin Hydrochloride

Product NDC: 42291-031
11-digit product format: 422910031
Labeler code: 42291
Product ID: 42291-031_48483bec-9af4-f1bd-e063-6294a90a8d84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dutasteride and Tamsulosin Hydrochloride Capsules
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA202509
Marketing category: ANDA
Marketing start: 2023-11-15
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-031		I	Inactivated by FDA		2026-08-03
excluded package	package	42291-031	42291-031-30	I	Inactivated by FDA		2026-08-03

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
A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2014-02-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A202509-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202509-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2014-02-26	`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	A202509-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202509-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202509-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202509-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202509-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202509-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202509-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202509-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202509-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202509-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202509-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202509-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202509-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202509-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202509-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202509-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202509-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202509-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202509-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202509-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202509-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202509-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202509-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202509-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202509-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202509-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202509-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202509-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202509-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202509-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202509-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202509-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202509-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202509-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202509-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202509-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202509-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202509-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202509-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202509-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee39297f-c54b-4394-13fa-e0de7b5b9070	Product name	4	20250305
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
ae349df8-97ce-a639-ed32-50a4cb01b1bd	Product name	4	20200313
15cfa3ee-23c6-c9fd-f216-95d9676ee575	Product name	9	20180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-031-30	Dutasteride and Tamsulosin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-031-30	EA - Each	42291-031	9c00f7e6-580b-472f-886d-e15f58f9d4e1	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-031	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [AVKARE]	1	Current NDC, 1 package rows	20231116_0a334eb9-cacf-f213-e063-6394a90a46da.zip

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	0a334eb9-cacf-f213-e063-6394a90a46da	2
996097	dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	0a334eb9-cacf-f213-e063-6394a90a46da	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-031-30	42291003130	30 CAPSULE in 1 BOTTLE (42291-031-30)	30 capsule	2023-11-15	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dutasteride and Tamsulosin Hydrochloride Capsules	AvKARE	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	2