Tamsulosin Hydrochloride

Product NDC
68382-132
11-digit product format
683820132
Labeler code
68382
Product ID
68382-132_ee9d9efd-0c79-4993-bfd7-d4c30e20bddd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
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
300be29a-c56d-4daa-ba89-f207c281ea20Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-132-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10015
68382-132-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE50015
68382-132-06Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE3015
68382-132-10Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE100015
68382-132-14Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE6015
68382-132-16Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE9015
68382-132-30Tamsulosin Hydrochloride1 in 1 BLISTER PACKCAPSULE115
68382-132-77Tamsulosin Hydrochloride100 in 1 CARTONCAPSULE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-132-01EA - Each68382-132d0b15e38-77dd-4626-9415-e8ea838cd27a12012-07-24
68382-132-10EA - Each68382-132b0f4c6b5-aca7-4bc5-9fb6-251c3748b0a312012-07-24
68382-132-16EA - Each68382-132beae02d2-9ba0-4a43-9241-2eb11944bcf312025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
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
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
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
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-132TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 8 package rows20231110_300be29a-c56d-4daa-ba89-f207c281ea20.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
ndc (product): 68382-132
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 CapsulePSN300be29a-c56d-4daa-ba89-f207c281ea2015
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD300be29a-c56d-4daa-ba89-f207c281ea2015
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY300be29a-c56d-4daa-ba89-f207c281ea2015
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 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
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1cfc75bd-69bb-e6c2-e063-6394a90ab60e1
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin HCl 0.4 MG Oral CapsulePSNc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin HCl 0.4 MG Oral CapsulePSN52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7350ad6e-7745-4743-9aa4-2a14ff01fef41
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7350ad6e-7745-4743-9aa4-2a14ff01fef41
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1cfc75bd-69bb-e6c2-e063-6394a90ab60e1
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7350ad6e-7745-4743-9aa4-2a14ff01fef41
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1cfc75bd-69bb-e6c2-e063-6394a90ab60e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-132-0168382013201100 CAPSULE in 1 BOTTLE (68382-132-01) 100 capsule2010-04-270000-00-00NoNoCurrent
68382-132-0568382013205500 CAPSULE in 1 BOTTLE (68382-132-05) 500 capsule2010-04-270000-00-00NoNoCurrent
68382-132-066838201320630 CAPSULE in 1 BOTTLE (68382-132-06) 30 capsule2010-04-270000-00-00NoNoCurrent
68382-132-10683820132101000 CAPSULE in 1 BOTTLE (68382-132-10) 1000 capsule2010-04-270000-00-00NoNoCurrent
68382-132-146838201321460 CAPSULE in 1 BOTTLE (68382-132-14) 60 capsule2010-04-270000-00-00NoNoCurrent
68382-132-166838201321690 CAPSULE in 1 BOTTLE (68382-132-16) 90 capsule2010-04-270000-00-00NoNoCurrent
68382-132-30683820132301 in 1 BLISTER PACKHistorical
68382-132-7768382013277100 BLISTER PACK in 1 CARTON (68382-132-77) / 1 CAPSULE in 1 BLISTER PACK (68382-132-30) 100 blister pack2010-04-270000-00-00NoNoCurrent