Tamsulosin Hydrochloride

Product NDC
68084-299
Requested package NDC
68084-299-01
11-digit product format
680840299
Labeler code
68084
Product ID
68084-299_38cbc0fa-ca6b-0e39-e063-6394a90abb97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078225
Marketing category
ANDA
Marketing start
2014-01-17
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 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
A078225-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALABRS2010-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078225-001AB

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 UTC2026-02A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALABRS2010-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALABRS2010-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALABRS2010-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALABRS2010-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273f01610625f2…
2019-09-15 20:21 UTC2019-09A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27cb3db0bc1861…

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 UTC2026-02A078225-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078225-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078225-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078225-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078225-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078225-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078225-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078225-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078225-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078225-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078225-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078225-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078225-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078225-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078225-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078225-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078225-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078225-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078225-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078225-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078225-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078225-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078225-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078225-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078225-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078225-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078225-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078225-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078225-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078225-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078225-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078225-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078225-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078225-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078225-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078225-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078225-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078225-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078225-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078225-001AB1cb3db0bc1861…

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
8150a710-aee5-4841-ae1b-7d2e61281a8fAvailable 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
68084-299-01Tamsulosin Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE10012
68084-299-11Tamsulosin Hydrochloride1 in 1 BLISTER PACKCAPSULE112
68084-299-65Tamsulosin Hydrochloride50 in 1 CARTONCAPSULE5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-299-01EA - Each68084-299f1555159-662a-4418-837f-36830648cd7612014-04-03
68084-299-11EA - Each68084-299571bb59e-6a4f-4274-8176-f7bad17498e612014-04-03
68084-299-65EA - Each68084-299edca93bd-5f18-40ea-acb0-a7ffd551dd5f12025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-299TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 3 package rows20250424_8150a710-aee5-4841-ae1b-7d2e61281a8f.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepacke9372720-bd02-e4a6-0afd-42fe0c661c002026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECardinal Health 107, LLC5ed219aa-cf65-457f-8570-d26b48edb2402026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECoupler LLC52bbe73b-43b6-3393-e063-6294a90a6dc62026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAmerican Health Packaging8150a710-aee5-4841-ae1b-7d2e61281a8f2025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225
ndc (package): 68084-299-01
ndc (product): 68084-299
ndc11 (package): 68084029901
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEZydus Lifesciences Limited276c7e26-f86a-46b9-b626-ceef76b729a42024-08-12Exact identifier
application applno (ANDA): 078225
application number: ANDA078225
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.300be29a-c56d-4daa-ba89-f207c281ea202023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC12ba3063-a134-41e2-8447-45933d4f0f582023-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc963384e-eb50-4462-9aea-ed9d26d267d62023-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8150a710-aee5-4841-ae1b-7d2e61281a8f12
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8150a710-aee5-4841-ae1b-7d2e61281a8f12
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8150a710-aee5-4841-ae1b-7d2e61281a8f12
863669tamsulosin HCl 0.4 MG Oral CapsulePSN5ed219aa-cf65-457f-8570-d26b48edb2403
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD5ed219aa-cf65-457f-8570-d26b48edb2403
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY5ed219aa-cf65-457f-8570-d26b48edb2403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-299-0168084029901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-299-01) / 1 CAPSULE in 1 BLISTER PACK (68084-299-11) 100 blister pack2014-01-170000-00-00NoNoCurrent