FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
67877-450
11-digit product format
678770450
Labeler code
67877
Product ID
67877-450_6803a320-4e6f-4f1a-bfcf-955daf90fa76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207405
Marketing category
ANDA
Marketing start
2017-08-11
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

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 Identifiers#

Field, Values table
FieldValues
Unii11SV1951MR
Rxcui863669

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
67877-450-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1009
67877-450-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE5009
67877-450-10Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE10009
67877-450-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE309
67877-450-33Tamsulosin Hydrochloride10 in 1 BLISTER PACKCAPSULE109
67877-450-38Tamsulosin Hydrochloride10 in 1 CARTONCAPSULE109
67877-450-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-450-01EA - Each67877-450380493aa-204c-4620-ada4-5dae8c8a29b312017-10-13
67877-450-05EA - Each67877-4505d56455a-1491-489e-a7e3-2fceb9d4d0a712017-10-13
67877-450-10EA - Each67877-450c3a5aa5b-d650-4c12-a16b-c3f2857f902512017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-450TAMSULOSIN HYDROCHLORIDE CAPSULE [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 7 package rows20221014_ed9988bc-0759-4c36-bee1-11b68dc1c84c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNed9988bc-0759-4c36-bee1-11b68dc1c84c9
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDed9988bc-0759-4c36-bee1-11b68dc1c84c9
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYed9988bc-0759-4c36-bee1-11b68dc1c84c9
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin HCl 0.4 MG Oral CapsulePSN74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin HCl 0.4 MG Oral CapsulePSN06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin HCl 0.4 MG Oral CapsulePSN18e9741b-969a-5a87-e063-6294a90a88512
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD18e9741b-969a-5a87-e063-6294a90a88512
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY18e9741b-969a-5a87-e063-6294a90a88512
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf4c298d5-affb-7b56-e053-2a95a90a3d551
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf4c298d5-affb-7b56-e053-2a95a90a3d551
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf4c298d5-affb-7b56-e053-2a95a90a3d551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-450-0167877045001100 CAPSULE in 1 BOTTLE (67877-450-01) 100 capsule2017-08-110000-00-00NoNoCurrent
67877-450-0567877045005500 CAPSULE in 1 BOTTLE (67877-450-05) 500 capsule2017-08-110000-00-00NoNoCurrent
67877-450-10678770450101000 CAPSULE in 1 BOTTLE (67877-450-10) 1000 capsule2017-08-110000-00-00NoNoCurrent
67877-450-306787704503030 CAPSULE in 1 BOTTLE (67877-450-30) 30 capsule2017-08-110000-00-00NoNoCurrent
67877-450-336787704503310 in 1 BLISTER PACKHistorical
67877-450-386787704503810 BLISTER PACK in 1 CARTON (67877-450-38) / 10 CAPSULE in 1 BLISTER PACK (67877-450-33) 10 blister pack2017-08-110000-00-00NoNoCurrent
67877-450-606787704506060 CAPSULE in 1 BOTTLE (67877-450-60) 60 capsule2017-08-110000-00-00NoNoCurrent