Tamsulosin Hydrochloride

Product NDC
65862-598
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-598UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage65862-59865862-598-22UNFINISHEDActive or certified unfinished drug listing2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-598-22a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-598-221d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-598-22390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-598-22e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-598-22bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-598-22f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-598-22f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-598-2268b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-598-2205c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-598-2248b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-598-2227f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-598-228d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-598-22d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-598-2250b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-598-22906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-598-226db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-598-228fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-598-224184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-598-224bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-598-22263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-598-225b2001dcd8f5…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202433-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202433-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202433-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202433-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202433-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202433-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202433-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202433-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202433-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202433-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202433-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202433-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202433-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202433-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202433-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202433-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202433-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202433-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202433-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202433-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202433-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202433-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202433-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202433-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202433-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202433-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202433-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202433-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202433-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202433-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202433-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202433-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202433-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202433-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202433-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202433-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202433-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202433-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202433-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202433-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202433-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202433-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11SV1951MRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863669Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8cb27f78-2d5d-4640-b7b5-ed06973c8133Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-598-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10016
65862-598-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE50016
65862-598-10Tamsulosin Hydrochloride10 in 1 BLISTER PACKCAPSULE1016
65862-598-10Tamsulosin Hydrochloride3 in 1 CARTONCAPSULE316

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-598TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 4 package rows20231118_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.a608ddc8-fe42-484e-b61f-307c601511382026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.b30e2bde-b20e-4899-a100-f44170d8165b2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack59d0e07c-0018-4681-beb2-cb1c8e2637ee2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDESt. Marys Medical Park Pharmacy6142d7b6-e5ea-1af0-e053-2991aa0a00cd2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDIRECT RX7a420aca-31e6-8e0c-e053-2a91aa0a1be02026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDirect_Rx8de50eca-8cc5-082d-e053-2a95a90a346d2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepackfd73ddfd-3773-45b2-9795-9e58744a68032026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERedpharm Drug4d481f6b-0232-d4af-e063-6394a90ad1af2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f543f5d1-3348-4066-99a4-7a00aee1530d2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERising Pharma Holdings, Inc.a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a2026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENorthwind Health Company, LLCd9df4fe0-90ab-0d96-e053-2a95a90a5ff12026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECardinal Health 107, LLC0e3206ba-db3e-40b3-b46b-c7ae4703fdea2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f6b6aeab-bedd-4254-8811-4f65cf8a351f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions6a2a4cc7-c88a-4555-a247-d1e63206ffc52025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions00bb2d71-1f21-494c-aa66-a82be3a0a8e62025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions1d70b04e-ca08-48d3-937b-eb701b40dd8a2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPreferred Pharmaceuticals, Inc.82d65964-de00-42c2-baaa-cc3de744b8eb2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEMajor Pharmaceuticalsf8302a6e-b8da-4931-a279-b49e379438162025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack36b8c36f-22e5-40f5-a99a-411115f13df42025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.cfd48327-a528-58cc-e053-2995a90a129f2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8cb27f78-2d5d-4640-b7b5-ed06973c813316
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8cb27f78-2d5d-4640-b7b5-ed06973c813316
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8cb27f78-2d5d-4640-b7b5-ed06973c813316
863669tamsulosin HCl 0.4 MG Oral CapsulePSN9631351f-66f4-45e5-a866-1e59311bd4d713
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD9631351f-66f4-45e5-a866-1e59311bd4d713
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY9631351f-66f4-45e5-a866-1e59311bd4d713
863669tamsulosin HCl 0.4 MG Oral CapsulePSN58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin HCl 0.4 MG Oral CapsulePSN6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin HCl 0.4 MG Oral CapsulePSN82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4fe6f814-a878-1247-e054-00144ff8d46c5
863669tamsulosin HCl 0.4 MG Oral CapsulePSN6142d7b6-e5ea-1af0-e053-2991aa0a00cd5
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4fe6f814-a878-1247-e054-00144ff8d46c5
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD6142d7b6-e5ea-1af0-e053-2991aa0a00cd5
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4fe6f814-a878-1247-e054-00144ff8d46c5
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY6142d7b6-e5ea-1af0-e053-2991aa0a00cd5
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Oral CapsulePSN25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Oral CapsulePSN985871d9-81e2-5fda-e053-2995a90a03383
863669tamsulosin HCl 0.4 MG Oral CapsulePSNd9df4fe0-90ab-0d96-e053-2a95a90a5ff13
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD985871d9-81e2-5fda-e053-2995a90a03383
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDd9df4fe0-90ab-0d96-e053-2a95a90a5ff13
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY985871d9-81e2-5fda-e053-2995a90a03383
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYd9df4fe0-90ab-0d96-e053-2a95a90a5ff13
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin HCl 0.4 MG Oral CapsulePSN01f390a6-bb2c-4293-9d3d-76b6bec094c22
863669tamsulosin HCl 0.4 MG Oral CapsulePSNe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin HCl 0.4 MG Oral CapsulePSN14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD01f390a6-bb2c-4293-9d3d-76b6bec094c22
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY01f390a6-bb2c-4293-9d3d-76b6bec094c22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin HCl 0.4 MG Oral CapsulePSN2642c5e1-47c1-b87b-e063-6294a90af6ce1
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD2642c5e1-47c1-b87b-e063-6294a90af6ce1
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY2642c5e1-47c1-b87b-e063-6294a90af6ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-598-0165862059801100 CAPSULE in 1 BOTTLE (65862-598-01) 100 capsule2013-04-300000-00-00NoNoCurrent
65862-598-0565862059805500 CAPSULE in 1 BOTTLE (65862-598-05) 500 capsule2013-04-300000-00-00NoNoCurrent
65862-598-10658620598103 BLISTER PACK in 1 CARTON (65862-598-10) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2013-04-300000-00-00NoNoCurrent
65862-598-22658620598222000 CAPSULE in 1 BAG (65862-598-22)2000 capsule30-APR-13Current