Tamsulosin Hydrochloride

Product NDC: 68071-2197
Requested package NDC: 68071-2197-6
11-digit product format: 680712197
Labeler code: 68071
Product ID: 68071-2197_c68fc96b-8d87-557a-e053-2a95a90aeffc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA202433
Marketing category: ANDA
Marketing start: 2013-04-30
Marketing end: 0000-00-00
Substance: TAMSULOSIN HYDROCHLORIDE
Active strength: 0 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2197	68071-2197-6	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A202433-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2013-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202433-001	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	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`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	A202433-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202433-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202433-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202433-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202433-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202433-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202433-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202433-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202433-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202433-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202433-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202433-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202433-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202433-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202433-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202433-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202433-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202433-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202433-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202433-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202433-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202433-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202433-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202433-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202433-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202433-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202433-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202433-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202433-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202433-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202433-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202433-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202433-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202433-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202433-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202433-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202433-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202433-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202433-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202433-001	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
ae349df8-97ce-a639-ed32-50a4cb01b1bd	Product name	4	20200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-2197-1	2023-01-30	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-3	2023-01-30	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-6	2023-01-30	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-9	2023-01-30	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-1	2021-07-07	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-3	2021-07-07	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-6	2021-07-07	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-9	2021-07-07	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-1	2021-01-29	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-3	2021-01-29	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-6	2021-01-29	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-2197-9	2021-01-29	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2197-1	Tamsulosin Hydrochloride	10 in 1 BOTTLE	CAPSULE	10	2
68071-2197-3	Tamsulosin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	2
68071-2197-6	Tamsulosin Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	2
68071-2197-9	Tamsulosin Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2197	TAMSULOSIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 4 package rows	20210708_4fbf72e0-c7e7-0a50-e054-00144ff8d46c.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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	REMEDYREPACK INC.	a608ddc8-fe42-484e-b61f-307c60151138	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	REMEDYREPACK INC.	b30e2bde-b20e-4899-a100-f44170d8165b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	59d0e07c-0018-4681-beb2-cb1c8e2637ee	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	St. Marys Medical Park Pharmacy	6142d7b6-e5ea-1af0-e053-2991aa0a00cd	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	DIRECT RX	7a420aca-31e6-8e0c-e053-2a91aa0a1be0	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Direct_Rx	8de50eca-8cc5-082d-e053-2a95a90a346d	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	fd73ddfd-3773-45b2-9795-9e58744a6803	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Redpharm Drug	4d481f6b-0232-d4af-e063-6394a90ad1af	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f543f5d1-3348-4066-99a4-7a00aee1530d	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Northwind Health Company, LLC	d9df4fe0-90ab-0d96-e053-2a95a90a5ff1	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Cardinal Health 107, LLC	0e3206ba-db3e-40b3-b46b-c7ae4703fdea	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f6b6aeab-bedd-4254-8811-4f65cf8a351f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	6a2a4cc7-c88a-4555-a247-d1e63206ffc5	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	00bb2d71-1f21-494c-aa66-a82be3a0a8e6	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	1d70b04e-ca08-48d3-937b-eb701b40dd8a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	82d65964-de00-42c2-baaa-cc3de744b8eb	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Major Pharmaceuticals	f8302a6e-b8da-4931-a279-b49e37943816	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	36b8c36f-22e5-40f5-a99a-411115f13df4	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	cfd48327-a528-58cc-e053-2995a90a129f	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433

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	4fbf72e0-c7e7-0a50-e054-00144ff8d46c	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	4fbf72e0-c7e7-0a50-e054-00144ff8d46c	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	4fbf72e0-c7e7-0a50-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2197-6	68071219706	60 CAPSULE in 1 BOTTLE (68071-2197-6)	60 capsule	2017-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamsulosin Hydrochloride	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceuticals, Inc.	2021-07-07	HUMAN PRESCRIPTION DRUG LABEL	2