Tamsulosin Hydrochloride

Product NDC: 67296-1739
11-digit product format: 672961739
Labeler code: 67296
Product ID: 67296-1739_d61f70ec-2e8a-34a0-e053-2a95a90a325e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA204645
Marketing category: ANDA
Marketing start: 2020-01-01
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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67296-1739		I	Inactivated by FDA	2026-10-05
excluded package	package	67296-1739	67296-1739-1	I	Inactivated by FDA	2026-10-05
excluded package	package	67296-1739	67296-1739-7	I	Inactivated by FDA	2026-10-05

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1739-7	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1739-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1739-7	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1739-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1739-7	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1739-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1739-7	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1739-1	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204645-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2017-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204645-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204645-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204645-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204645-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204645-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204645-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204645-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204645-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204645-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204645-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204645-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204645-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204645-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204645-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204645-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204645-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204645-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204645-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204645-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204645-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204645-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204645-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204645-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204645-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204645-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204645-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204645-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204645-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204645-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204645-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204645-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204645-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204645-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204645-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204645-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204645-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204645-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204645-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204645-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204645-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204645-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
67296-1739-1	2026-01-29	Tamsulosin 0.4mg
67296-1739-7	2026-01-29	Tamsulosin 0.4mg
67296-1739-1	2024-08-02	Tamsulosin 0.4mg
67296-1739-7	2024-08-02	Tamsulosin 0.4mg
67296-1739-1	2024-01-30	Tamsulosin 0.4mg
67296-1739-7	2024-01-30	Tamsulosin 0.4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1739-1	Tamsulosin Hydrochloride	10 in 1 BOTTLE	CAPSULE	10		7
67296-1739-7	Tamsulosin Hydrochloride	7 in 1 BOTTLE	CAPSULE	7		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1739	TAMSULOSIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]	7	Legacy NDC, 2 package rows	20240805_a3362c28-7caf-df91-e053-2995a90a3d0e.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 · 4 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	3533e74e-5706-f594-e063-6394a90ab8a7	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204645 application number: ANDA204645
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b85769ba-814e-1adb-e053-2a95a90a0556	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204645 application number: ANDA204645
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	87618dfd-eae4-2532-e053-2a95a90a10a0	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204645 application number: ANDA204645
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Macleods Pharmaceuticals Limited	2912fbbc-89bf-4bf0-86fe-bd98f3168e84	2022-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204645 application number: ANDA204645

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	a3362c28-7caf-df91-e053-2995a90a3d0e	7
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	a3362c28-7caf-df91-e053-2995a90a3d0e	7
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	a3362c28-7caf-df91-e053-2995a90a3d0e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1739-1	67296173901	10 CAPSULE in 1 BOTTLE (67296-1739-1)	10 capsule	2020-01-01	0000-00-00	No	No	Current
67296-1739-7	67296173907	7 CAPSULE in 1 BOTTLE (67296-1739-7)	7 capsule	2020-01-01	0000-00-00	No	No	Current