Tamsulosin Hydrochloride

Product NDC: 71335-1538
11-digit product format: 713351538
Labeler code: 71335
Product ID: 71335-1538_9f11a118-1a0e-4fa2-a6c0-1258f965c905
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207405
Marketing category: ANDA
Marketing start: 2017-08-11
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
A207405-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2017-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207405-001	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	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207405-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-08-11	`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	A207405-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207405-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207405-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207405-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207405-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207405-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207405-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207405-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207405-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207405-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207405-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207405-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207405-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207405-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207405-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207405-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207405-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207405-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207405-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207405-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207405-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207405-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207405-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207405-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207405-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207405-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207405-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207405-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207405-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207405-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207405-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207405-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207405-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207405-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207405-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207405-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207405-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207405-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207405-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207405-001	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
f185abfc-367d-45da-87c4-86d9f70bcd5d	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	SPL version
71335-1538-0	Tamsulosin Hydrochloride	3 in 1 BOTTLE	CAPSULE	3	5
71335-1538-1	Tamsulosin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	5
71335-1538-2	Tamsulosin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	5
71335-1538-3	Tamsulosin Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	5
71335-1538-4	Tamsulosin Hydrochloride	10 in 1 BOTTLE	CAPSULE	10	5
71335-1538-5	Tamsulosin Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	5
71335-1538-6	Tamsulosin Hydrochloride	180 in 1 BOTTLE	CAPSULE	180	5
71335-1538-7	Tamsulosin Hydrochloride	7 in 1 BOTTLE	CAPSULE	7	5
71335-1538-8	Tamsulosin Hydrochloride	15 in 1 BOTTLE	CAPSULE	15	5
71335-1538-9	Tamsulosin Hydrochloride	120 in 1 BOTTLE	CAPSULE	120	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1538	TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	4	Current NDC, Legacy NDC, 10 package rows	20240830_f185abfc-367d-45da-87c4-86d9f70bcd5d.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Chartwell RX, LLC	14db58df-7584-410b-8cf4-4b928dada859	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	AvPAK	62fa7fdf-c588-6f79-e053-2a91aa0a4c19	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	18e9741b-969a-5a87-e063-6294a90a8851	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	f185abfc-367d-45da-87c4-86d9f70bcd5d	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405 ndc (product): 71335-1538
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Ascend Laboratories, LLC	ed9988bc-0759-4c36-bee1-11b68dc1c84c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	3a05970e-6c34-4dff-9fd7-dde8ce60f280	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	74a8ef78-908f-4671-91a3-ec3a044aabf2	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	06b44e53-c6e7-4e12-a8fd-572d092cfa70	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207405 application number: ANDA207405

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	f185abfc-367d-45da-87c4-86d9f70bcd5d	5
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	f185abfc-367d-45da-87c4-86d9f70bcd5d	5
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	f185abfc-367d-45da-87c4-86d9f70bcd5d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1538-0	71335153800	3 CAPSULE in 1 BOTTLE (71335-1538-0)	3 capsule	2020-03-20		No	No	Current
71335-1538-1	71335153801	30 CAPSULE in 1 BOTTLE (71335-1538-1)	30 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-2	71335153802	100 CAPSULE in 1 BOTTLE (71335-1538-2)	100 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-3	71335153803	60 CAPSULE in 1 BOTTLE (71335-1538-3)	60 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-4	71335153804	10 CAPSULE in 1 BOTTLE (71335-1538-4)	10 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-5	71335153805	90 CAPSULE in 1 BOTTLE (71335-1538-5)	90 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-6	71335153806	180 CAPSULE in 1 BOTTLE (71335-1538-6)	180 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-7	71335153807	7 CAPSULE in 1 BOTTLE (71335-1538-7)	7 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-8	71335153808	15 CAPSULE in 1 BOTTLE (71335-1538-8)	15 capsule	2020-03-20	0000-00-00	No	No	Current
71335-1538-9	71335153809	120 CAPSULE in 1 BOTTLE (71335-1538-9)	120 capsule	2020-03-20	0000-00-00	No	No	Current