Tamsulosin Hydrochloride

Product NDC: 65862-598
Requested package NDC: 65862-598-22
11-digit product format: 658620598
Labeler code: 65862
Product ID: 65862-598_94771a21-3051-46cc-8deb-200bc9f3dcb3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamsulosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA202433
Marketing category: ANDA
Marketing start: 2013-04-30
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

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
unfinished package	package	65862-598	65862-598-22	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

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 · 21 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202433-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB		2013-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202433-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202433-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2013-04-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202433-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202433-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202433-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202433-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202433-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202433-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202433-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202433-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202433-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202433-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202433-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202433-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202433-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202433-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202433-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202433-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202433-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202433-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202433-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202433-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202433-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202433-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202433-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202433-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202433-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202433-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202433-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202433-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202433-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202433-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202433-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202433-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202433-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202433-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202433-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202433-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202433-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202433-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202433-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202433-001	AB	1	`cb3db0bc1861…`

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
8cb27f78-2d5d-4640-b7b5-ed06973c8133	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
ae349df8-97ce-a639-ed32-50a4cb01b1bd	Product name	4	20200313
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-598-01	Tamsulosin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	16
65862-598-05	Tamsulosin Hydrochloride	500 in 1 BOTTLE	CAPSULE	500	16
65862-598-10	Tamsulosin Hydrochloride	10 in 1 BLISTER PACK	CAPSULE	10	16
65862-598-10	Tamsulosin Hydrochloride	3 in 1 CARTON	CAPSULE	3	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TAMSULOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-598	TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	16	Current NDC, Legacy NDC, 4 package rows	20231118_8cb27f78-2d5d-4640-b7b5-ed06973c8133.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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	REMEDYREPACK INC.	a608ddc8-fe42-484e-b61f-307c60151138	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	REMEDYREPACK INC.	b30e2bde-b20e-4899-a100-f44170d8165b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	59d0e07c-0018-4681-beb2-cb1c8e2637ee	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	St. Marys Medical Park Pharmacy	6142d7b6-e5ea-1af0-e053-2991aa0a00cd	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	DIRECT RX	7a420aca-31e6-8e0c-e053-2a91aa0a1be0	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	Direct_Rx	8de50eca-8cc5-082d-e053-2a95a90a346d	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	fd73ddfd-3773-45b2-9795-9e58744a6803	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Redpharm Drug	4d481f6b-0232-d4af-e063-6394a90ad1af	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f543f5d1-3348-4066-99a4-7a00aee1530d	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Northwind Health Company, LLC	d9df4fe0-90ab-0d96-e053-2a95a90a5ff1	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Cardinal Health 107, LLC	0e3206ba-db3e-40b3-b46b-c7ae4703fdea	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f6b6aeab-bedd-4254-8811-4f65cf8a351f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	6a2a4cc7-c88a-4555-a247-d1e63206ffc5	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	00bb2d71-1f21-494c-aa66-a82be3a0a8e6	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	A-S Medication Solutions	1d70b04e-ca08-48d3-937b-eb701b40dd8a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	82d65964-de00-42c2-baaa-cc3de744b8eb	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Major Pharmaceuticals	f8302a6e-b8da-4931-a279-b49e37943816	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	Bryant Ranch Prepack	36b8c36f-22e5-40f5-a99a-411115f13df4	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433
Tamsulosin Hydrochloride	TAMSULOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	cfd48327-a528-58cc-e053-2995a90a129f	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202433 application number: ANDA202433

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	36b8c36f-22e5-40f5-a99a-411115f13df4	100
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	36b8c36f-22e5-40f5-a99a-411115f13df4	100
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	36b8c36f-22e5-40f5-a99a-411115f13df4	100
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	f6b6aeab-bedd-4254-8811-4f65cf8a351f	22
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	f6b6aeab-bedd-4254-8811-4f65cf8a351f	22
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	f6b6aeab-bedd-4254-8811-4f65cf8a351f	22
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	a608ddc8-fe42-484e-b61f-307c60151138	17
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	a608ddc8-fe42-484e-b61f-307c60151138	17
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	a608ddc8-fe42-484e-b61f-307c60151138	17
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	8cb27f78-2d5d-4640-b7b5-ed06973c8133	16
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	8cb27f78-2d5d-4640-b7b5-ed06973c8133	16
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	8cb27f78-2d5d-4640-b7b5-ed06973c8133	16
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	9631351f-66f4-45e5-a866-1e59311bd4d7	13
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	9631351f-66f4-45e5-a866-1e59311bd4d7	13
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	9631351f-66f4-45e5-a866-1e59311bd4d7	13
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	58bdac81-680a-4fd2-8f05-dd5b86553569	8
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	58bdac81-680a-4fd2-8f05-dd5b86553569	8
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	58bdac81-680a-4fd2-8f05-dd5b86553569	8
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	6cb939a6-2bc6-5ca0-e053-2991aa0a4e69	7
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	6cb939a6-2bc6-5ca0-e053-2991aa0a4e69	7
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	6cb939a6-2bc6-5ca0-e053-2991aa0a4e69	7
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	82d65964-de00-42c2-baaa-cc3de744b8eb	6
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	1d70b04e-ca08-48d3-937b-eb701b40dd8a	6
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	1d70b04e-ca08-48d3-937b-eb701b40dd8a	6
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	82d65964-de00-42c2-baaa-cc3de744b8eb	6
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	1d70b04e-ca08-48d3-937b-eb701b40dd8a	6
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	82d65964-de00-42c2-baaa-cc3de744b8eb	6
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	4fe6f814-a878-1247-e054-00144ff8d46c	5
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	6142d7b6-e5ea-1af0-e053-2991aa0a00cd	5
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	4fe6f814-a878-1247-e054-00144ff8d46c	5
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	6142d7b6-e5ea-1af0-e053-2991aa0a00cd	5
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	4fe6f814-a878-1247-e054-00144ff8d46c	5
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	6142d7b6-e5ea-1af0-e053-2991aa0a00cd	5
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	8de50eca-8cc5-082d-e053-2a95a90a346d	4
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	25d5ceab-a04b-4cf0-bc48-3d0c6d8af006	4
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	25d5ceab-a04b-4cf0-bc48-3d0c6d8af006	4
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	8de50eca-8cc5-082d-e053-2a95a90a346d	4
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	25d5ceab-a04b-4cf0-bc48-3d0c6d8af006	4
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	8de50eca-8cc5-082d-e053-2a95a90a346d	4
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	985871d9-81e2-5fda-e053-2995a90a0338	3
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	d9df4fe0-90ab-0d96-e053-2a95a90a5ff1	3
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	f8302a6e-b8da-4931-a279-b49e37943816	3
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	985871d9-81e2-5fda-e053-2995a90a0338	3
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	f8302a6e-b8da-4931-a279-b49e37943816	3
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	d9df4fe0-90ab-0d96-e053-2a95a90a5ff1	3
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	f8302a6e-b8da-4931-a279-b49e37943816	3
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	985871d9-81e2-5fda-e053-2995a90a0338	3
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	d9df4fe0-90ab-0d96-e053-2a95a90a5ff1	3
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	f0ac7598-8e98-47e3-a9f7-ee393d807ca2	2
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	01f390a6-bb2c-4293-9d3d-76b6bec094c2	2
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	e0ad49c7-f57c-45c6-9084-16d8b79c8f87	2
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	14c1fc86-76bd-499d-871a-e6830bea2322	2
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	7a420aca-31e6-8e0c-e053-2a91aa0a1be0	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	14c1fc86-76bd-499d-871a-e6830bea2322	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	01f390a6-bb2c-4293-9d3d-76b6bec094c2	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	7a420aca-31e6-8e0c-e053-2a91aa0a1be0	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	e0ad49c7-f57c-45c6-9084-16d8b79c8f87	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	f0ac7598-8e98-47e3-a9f7-ee393d807ca2	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	01f390a6-bb2c-4293-9d3d-76b6bec094c2	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	e0ad49c7-f57c-45c6-9084-16d8b79c8f87	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	14c1fc86-76bd-499d-871a-e6830bea2322	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	f0ac7598-8e98-47e3-a9f7-ee393d807ca2	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	7a420aca-31e6-8e0c-e053-2a91aa0a1be0	2
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	2642c5e1-47c1-b87b-e063-6294a90af6ce	1
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	2642c5e1-47c1-b87b-e063-6294a90af6ce	1
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	2642c5e1-47c1-b87b-e063-6294a90af6ce	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-598-22	65862059822	2000 CAPSULE in 1 BAG (65862-598-22)	2000 capsule	30-APR-13	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamsulosin Hydrochloride	REMEDYREPACK INC.	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	18
Tamsulosin Hydrochloride	St. Mary’s Medical Park Pharmacy	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	5
TAMSULOSIN HYDROCHLORIDE	DIRECT RX	2026-04-22	HUMAN PRESCRIPTION DRUG LABEL	2
TAMSULOSIN HYDROCHLORIDE	Direct_Rx	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	4
Tamsulosin Hydrochloride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Tamsulosin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	22
Tamsulosin Hydrochloride	A-S Medication Solutions	2025-10-02	Human Prescription Drug Label	6
Tamsulosin Hydrochloride	Preferred Pharmaceuticals, Inc.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	6
Tamsulosin Hydrochloride	Major Pharmaceuticals	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL	3
Tamsulosin Hydrochloride	Bryant Ranch Prepack	2025-05-23	HUMAN PRESCRIPTION DRUG LABEL	100
Tamsulosin Hydrochloride	Coupler LLC	2024-11-06	HUMAN PRESCRIPTION DRUG LABEL	1
Tamsulosin Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	5
Tamsulosin Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
Tamsulosin Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	7
Tamsulosin Hydrochloride	Bryant Ranch Prepack	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	8
Tamsulosin Hydrochloride	A-S Medication Solutions	2024-01-31	Human Prescription Drug Label	13
Tamsulosin Hydrochloride	Aurobindo Pharma Limited	2023-11-17	Human Prescription Drug Label	16
Tamsulosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2023-09-26	Human Prescription Drug Label	2
Tamsulosin Hydrochloride	RPK Pharmaceuticals, Inc.	2023-09-11	Human Prescription Drug Label	2