Tamsulosin hydrochloride

Product NDC: 43063-264
Requested package NDC: 43063-264-01
11-digit product format: 430630264
Labeler code: 43063
Product ID: 43063-264_d5f431b3-fe3d-7ddd-e053-2995a90ad815
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, 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: 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	43063-264	43063-264-01	D	Discontinued by firm		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 · 10 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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-264-01	EA - Each	43063-264	cc63ad23-4b06-4b62-b490-6878795c5682	1	2012-07-24
43063-264-30	EA - Each	43063-264	7b75ef61-d641-4a53-8094-62ded44d8235	1	2015-08-04
43063-264-90	EA - Each	43063-264	688a9bef-b1cf-47b9-a7da-567eb956bae1	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
tamsulosin hydrochloride	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
tamsulosin	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
shellac	INACTIVE INGREDIENT	46N107B71O	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-264-01	43063026401	100 CAPSULE in 1 BOTTLE, PLASTIC (43063-264-01)	100 capsule	2010-04-28	0000-00-00	No	No	Current