Tamsulosin hydrochloride

Product NDC: 76282-744
11-digit product format: 762820744
Labeler code: 76282
Product ID: 76282-744_06b18b22-60b7-486b-a87c-17a2ae4cfe41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: EXELAN PHARMACEUTICALS, INC.
Application: ANDA078801
Marketing category: ANDA
Marketing start: 2024-03-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078801-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		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
A078801-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078801-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078801-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078801-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078801-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078801-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078801-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078801-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078801-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078801-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078801-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078801-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078801-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078801-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078801-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078801-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078801-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078801-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078801-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078801-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078801-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078801-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078801-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078801-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078801-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078801-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078801-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078801-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078801-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078801-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078801-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078801-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078801-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078801-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078801-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078801-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078801-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078801-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078801-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078801-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078801-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078801-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tamsulosin hydrochloride
Listing expiration: 2026-12-31

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
db6cb771-2cff-40b7-a5ef-ea3cf2a3b461	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
76282-744-05	Tamsulosin hydrochloride	500 in 1 BOTTLE	CAPSULE	500		5
76282-744-90	Tamsulosin hydrochloride	90 in 1 BOTTLE	CAPSULE	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-744-05	EA - Each	76282-744	53bcf93a-03f7-490b-9f48-f360c4561d36	1	2024-05-16
76282-744-90	EA - Each	76282-744	905f8838-7e5a-459f-b1a2-4c5a3bee2153	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-744	TAMSULOSIN HYDROCHLORIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]	5	Current NDC, 2 package rows	20250330_db6cb771-2cff-40b7-a5ef-ea3cf2a3b461.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Synthon Pharmaceuticals, Inc.	13a5032d-0be1-4001-916e-459f0b1a051d	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078801 application number: ANDA078801
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	35bbb655-19e2-00c2-e063-6394a90afbe3	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078801 application number: ANDA078801
Tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	EXELAN PHARMACEUTICALS, INC.	db6cb771-2cff-40b7-a5ef-ea3cf2a3b461	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078801 application number: ANDA078801 ndc (product): 76282-744

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	db6cb771-2cff-40b7-a5ef-ea3cf2a3b461	5
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	db6cb771-2cff-40b7-a5ef-ea3cf2a3b461	5
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	db6cb771-2cff-40b7-a5ef-ea3cf2a3b461	5
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	35bbb655-19e2-00c2-e063-6394a90afbe3	1
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	35bbb655-19e2-00c2-e063-6394a90afbe3	1
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	35bbb655-19e2-00c2-e063-6394a90afbe3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76282-744-05	76282074405	500 CAPSULE in 1 BOTTLE (76282-744-05)	500 capsule	2024-03-01	No	No	Current
76282-744-90	76282074490	90 CAPSULE in 1 BOTTLE (76282-744-90)	90 capsule	2025-03-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamsulosin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2025-05-22	HUMAN PRESCRIPTION DRUG LABEL	1
Tamsulosin hydrochloride	EXELAN PHARMACEUTICALS, INC. \| Synthon Hispania S.L.	2025-03-01	HUMAN PRESCRIPTION DRUG LABEL	5