Tamsulosin Hydrochloride

Product NDC: 68071-1840
Requested package NDC: 68071-1840-1
11-digit product format: 680711840
Labeler code: 68071
Product ID: 68071-1840_2abbafda-0b5f-8778-e063-6294a90a7c75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA204645
Marketing category: ANDA
Marketing start: 2017-01-25
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

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 · 6 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
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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A204645-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2017-01-20	`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	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…`
2022-09-29 23:25 UTC	2022-09	A204645-001	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
b85769ba-814e-1adb-e053-2a95a90a0556	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1840-1	2025-01-02	C162847	48780-1	f386c649-f095-0266-e053-dadaa90a7c1a	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
68071-1840-1	2023-01-30	C162847	48780-1	f386c649-f095-0266-e053-dadaa90a7c1a	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	Strength	SPL version
68071-1840-1	Tamsulosin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1840	TAMSULOSIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 1 package rows	20250104_b85769ba-814e-1adb-e053-2a95a90a0556.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 ndc (package): 68071-1840-1 ndc (product): 68071-1840 ndc11 (package): 68071184001
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	b85769ba-814e-1adb-e053-2a95a90a0556	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	b85769ba-814e-1adb-e053-2a95a90a0556	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	b85769ba-814e-1adb-e053-2a95a90a0556	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1840-1	68071184001	100 CAPSULE in 1 BOTTLE (68071-1840-1)	100 capsule	2021-01-07	0000-00-00	No	No	Current