Tamsulosin Hydrochloride

Product NDC: 67046-1015
Requested package NDC: 67046-1015-3
11-digit product format: 670461015
Labeler code: 67046
Product ID: 67046-1015_52bbd288-9556-e73c-e063-6294a90a1671
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA078225
Marketing category: ANDA
Marketing start: 2026-05-26
Substance: TAMSULOSIN HYDROCHLORIDE
Active strength: .4 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A078225-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	RS	2010-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078225-001	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	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	RS	2010-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	RS	2010-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	RS	2010-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	RS	2010-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078225-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2010-04-27	`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	A078225-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078225-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078225-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078225-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078225-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078225-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078225-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078225-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078225-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078225-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078225-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078225-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078225-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078225-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078225-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078225-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078225-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078225-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078225-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078225-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078225-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078225-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078225-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078225-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078225-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078225-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078225-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078225-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078225-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078225-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078225-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078225-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078225-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078225-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078225-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078225-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078225-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078225-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078225-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078225-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tamsulosin Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TAMSULOSIN HYDROCHLORIDE	.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
11SV1951MR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
863669	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
52bbe73b-43b6-3393-e063-6294a90a6dc6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee39297f-c54b-4394-13fa-e0de7b5b9070	Product name	4	20250305
ae349df8-97ce-a639-ed32-50a4cb01b1bd	Product name	4	20200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-1015-3	Tamsulosin Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30		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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	e9372720-bd02-e4a6-0afd-42fe0c661c00	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078225 application number: ANDA078225
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Cardinal Health 107, LLC	5ed219aa-cf65-457f-8570-d26b48edb240	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078225 application number: ANDA078225
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Coupler LLC	52bbe73b-43b6-3393-e063-6294a90a6dc6	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078225 application number: ANDA078225 ndc (package): 67046-1015-3 ndc (product): 67046-1015 ndc11 (package): 67046101503
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	American Health Packaging	8150a710-aee5-4841-ae1b-7d2e61281a8f	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078225 application number: ANDA078225
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Zydus Lifesciences Limited	276c7e26-f86a-46b9-b626-ceef76b729a4	2024-08-12		Exact identifier application applno (ANDA): 078225 application number: ANDA078225
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	300be29a-c56d-4daa-ba89-f207c281ea20	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078225 application number: ANDA078225
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	12ba3063-a134-41e2-8447-45933d4f0f58	2023-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078225 application number: ANDA078225
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c963384e-eb50-4462-9aea-ed9d26d267d6	2023-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078225 application number: ANDA078225

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
11SV1951MR	TAMSULOSIN HYDROCHLORIDE	106463-17-6	TAMSULOSIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	52bbe73b-43b6-3393-e063-6294a90a6dc6	1
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	52bbe73b-43b6-3393-e063-6294a90a6dc6	1
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	52bbe73b-43b6-3393-e063-6294a90a6dc6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1015-3	67046101503	30 CAPSULE in 1 BLISTER PACK (67046-1015-3)	30 capsule	2026-05-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamsulosin Hydrochloride	Coupler LLC \| Zydus Pharmaceuticals USA Inc.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	1