Tamsulosin hydrochloride

Product NDC: 67296-0802
Requested package NDC: 67296-0802-2
11-digit product format: 672960802
Labeler code: 67296
Product ID: 67296-0802_be375ea5-3f13-35ec-e053-2995a90a4d8e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA078801
Marketing category: ANDA
Marketing start: 2010-04-27
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	67296-0802	67296-0802-2	I	Inactivated by FDA		2026-08-17

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0802-1	2023-01-30	C162847	48780-1	f386c649-ad61-0266-e053-dadaa90a7c1a	428b176a-a1b6-2f8a-e054-00144ff8d46c
67296-0802-2	2023-01-30	C162847	48780-1	f386c649-ad61-0266-e053-dadaa90a7c1a	428b176a-a1b6-2f8a-e054-00144ff8d46c
67296-0802-3	2023-01-30	C162847	48780-1	f386c649-ad61-0266-e053-dadaa90a7c1a	428b176a-a1b6-2f8a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-0802-1	Tamsulosin hydrochloride	7 in 1 BOTTLE	CAPSULE	7	3
67296-0802-2	Tamsulosin hydrochloride	10 in 1 BOTTLE	CAPSULE	10	3
67296-0802-3	Tamsulosin hydrochloride	30 in 1 BOTTLE	CAPSULE	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0802	TAMSULOSIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]	3	Legacy NDC, 3 package rows	20210324_428b176a-a1b6-2f8a-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 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

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	428b176a-a1b6-2f8a-e054-00144ff8d46c	3
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	428b176a-a1b6-2f8a-e054-00144ff8d46c	3
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	428b176a-a1b6-2f8a-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0802-2	67296080202	10 CAPSULE in 1 BOTTLE (67296-0802-2)	10 capsule	2010-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamsulosin hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2021-03-23	HUMAN PRESCRIPTION DRUG LABEL	3