Tamsulosin Hydrochloride

Product NDC
63187-469
11-digit product format
631870469
Labeler code
63187
Product ID
63187-469_3e498751-4077-47d5-803e-564ffb541dbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090931
Marketing category
ANDA
Marketing start
2010-07-15
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090931-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153f01610625f2…
2019-09-15 20:21 UTC2019-09A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090931-001AB15bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10A090931-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090931-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090931-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090931-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090931-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090931-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090931-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090931-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090931-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090931-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090931-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090931-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090931-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090931-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090931-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090931-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090931-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090931-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090931-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090931-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090931-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090931-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090931-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090931-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090931-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090931-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090931-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090931-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090931-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090931-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090931-001AB1cb3db0bc1861…

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
bf583b4a-a99c-4e18-a6d1-8609b5db1a3aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-469-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
63187-469-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE604
63187-469-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-469TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20210114_bf583b4a-a99c-4e18-a6d1-8609b5db1a3a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEProficient Rx LPbf583b4a-a99c-4e18-a6d1-8609b5db1a3a2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090931
application number: ANDA090931
ndc (product): 63187-469
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.d742707b-4c17-4b08-a9d0-491ba2bf64152020-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090931
application number: ANDA090931

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-469-306318704693030 CAPSULE in 1 BOTTLE (63187-469-30) 30 capsule2015-02-020000-00-00NoNoCurrent
63187-469-606318704696060 CAPSULE in 1 BOTTLE (63187-469-60) 60 capsule2015-02-020000-00-00NoNoCurrent
63187-469-906318704699090 CAPSULE in 1 BOTTLE (63187-469-90) 90 capsule2015-02-020000-00-00NoNoCurrent