Tamsulosin Hydrochloride

Product NDC
63629-4346
11-digit product format
636294346
Labeler code
63629
Product ID
63629-4346_660d7436-8f1d-466b-b8d5-c67e5e2cdfe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078225
Marketing category
ANDA
Marketing start
2010-04-27
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2027-12-31

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
e9372720-bd02-e4a6-0afd-42fe0c661c00Available 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
63629-4346-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE3011
63629-4346-2Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10011
63629-4346-3Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE6011
63629-4346-4Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE1011
63629-4346-5Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE9011
63629-4346-6Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE18011
63629-4346-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE711
63629-4346-8Tamsulosin Hydrochloride15 in 1 BOTTLECAPSULE1511
63629-4346-9Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE12011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4346TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]11Current NDC, 9 package rows20240310_e9372720-bd02-e4a6-0afd-42fe0c661c00.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
ndc (product): 63629-4346
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNe9372720-bd02-e4a6-0afd-42fe0c661c0011
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDe9372720-bd02-e4a6-0afd-42fe0c661c0011
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYe9372720-bd02-e4a6-0afd-42fe0c661c0011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4346-0636294346003 CAPSULE in 1 BOTTLE (63629-4346-0)3 capsule2024-03-080Current
63629-4346-16362943460130 CAPSULE in 1 BOTTLE (63629-4346-1) 30 capsule2024-03-08NoNoCurrent
63629-4346-263629434602100 CAPSULE in 1 BOTTLE (63629-4346-2) 100 capsule2024-03-08NoNoCurrent
63629-4346-36362943460360 CAPSULE in 1 BOTTLE (63629-4346-3) 60 capsule2024-03-08NoNoCurrent
63629-4346-46362943460410 CAPSULE in 1 BOTTLE (63629-4346-4) 10 capsule2024-03-08NoNoCurrent
63629-4346-56362943460590 CAPSULE in 1 BOTTLE (63629-4346-5) 90 capsule2024-03-08NoNoCurrent
63629-4346-663629434606180 CAPSULE in 1 BOTTLE (63629-4346-6) 180 capsule2024-03-08NoNoCurrent
63629-4346-7636294346077 CAPSULE in 1 BOTTLE (63629-4346-7) 7 capsule2024-03-08NoNoCurrent
63629-4346-86362943460815 CAPSULE in 1 BOTTLE (63629-4346-8) 15 capsule2024-03-08NoNoCurrent
63629-4346-963629434609120 CAPSULE in 1 BOTTLE (63629-4346-9) 120 capsule2024-03-08NoNoCurrent