Tamsulosin Hydrochloride

Product NDC
63739-567
Requested package NDC
63739-567-10
11-digit product format
637390567
Labeler code
63739
Product ID
63739-567_e27141f5-20a2-2be9-e053-2995a90a4ef0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA078225
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63739-56763739-567-10DDiscontinued by firm2026-08-17

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
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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078225-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALABRS2010-04-27caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078225-001AB1caaa826d4ba7…
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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-567-10EA - Each63739-567ddc145ce-9438-45fa-9413-5017df46804012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-567TAMSULOSIN HYDROCHLORIDE CAPSULE [MCKESSON CORPORATION DBA SKY PACKAGING]14Legacy NDC20250115_c9084267-e096-4dfb-b364-1a218c9d6985.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e4202c52-be9d-41d9-b5ff-1227402985442026-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078225
application number: ANDA078225
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-567-106373905671010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-567-10) > 10 CAPSULE in 1 BLISTER PACK10 blister pack2010-04-270000-00-00NoNoCurrent