Tamsulosin Hydrochloride

Product NDC: 68071-1934
Requested package NDC: 68071-1934-1
11-digit product format: 680711934
Labeler code: 68071
Product ID: 68071-1934_ed24e789-ff48-0be6-e053-2995a90a4135
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA090931
Marketing category: ANDA
Marketing start: 2010-07-15
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-1934	68071-1934-1	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 · 9 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	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A090931-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL			2010-07-15

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	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090931-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-07-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090931-001	AB	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A090931-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090931-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090931-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090931-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090931-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090931-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090931-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090931-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090931-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090931-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090931-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090931-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090931-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090931-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090931-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090931-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090931-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090931-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090931-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090931-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090931-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090931-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090931-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090931-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090931-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090931-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090931-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090931-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090931-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090931-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090931-001	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, Related label table
NDC	Related label
68071-1934-1	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-1934-3	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-1934-6	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-1934-9	These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE 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
68071-1934-1	Tamsulosin Hydrochloride	10 in 1 BOTTLE	CAPSULE	10	4
68071-1934-3	Tamsulosin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	4
68071-1934-6	Tamsulosin Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	4
68071-1934-9	Tamsulosin Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1934	TAMSULOSIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS, INC.]	4	Legacy NDC, 4 package rows	20221111_49245aec-9a0f-459e-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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	bf583b4a-a99c-4e18-a6d1-8609b5db1a3a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090931 application number: ANDA090931
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d742707b-4c17-4b08-a9d0-491ba2bf6415	2020-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090931 application number: ANDA090931

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	49245aec-9a0f-459e-e054-00144ff8d46c	4
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	49245aec-9a0f-459e-e054-00144ff8d46c	4
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	49245aec-9a0f-459e-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1934-1	68071193401	10 CAPSULE in 1 BOTTLE (68071-1934-1)	10 capsule	2017-02-22	0000-00-00	No	No	Current