FDA.reportPublic FDA data

Tamsulosin hydrochloride

Product NDC
76282-744
11-digit product format
762820744
Labeler code
76282
Product ID
76282-744_06b18b22-60b7-486b-a87c-17a2ae4cfe41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS, INC.
Application
ANDA078801
Marketing category
ANDA
Marketing start
2024-03-01
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-744-05Tamsulosin hydrochloride500 in 1 BOTTLECAPSULE5005
76282-744-90Tamsulosin hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-744-05EA - Each76282-74453bcf93a-03f7-490b-9f48-f360c4561d3612024-05-16
76282-744-90EA - Each76282-744905f8838-7e5a-459f-b1a2-4c5a3bee215312025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-744TAMSULOSIN HYDROCHLORIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20250330_db6cb771-2cff-40b7-a5ef-ea3cf2a3b461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNdb6cb771-2cff-40b7-a5ef-ea3cf2a3b4615
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDdb6cb771-2cff-40b7-a5ef-ea3cf2a3b4615
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYdb6cb771-2cff-40b7-a5ef-ea3cf2a3b4615
863669tamsulosin HCl 0.4 MG Oral CapsulePSN35bbb655-19e2-00c2-e063-6394a90afbe31
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD35bbb655-19e2-00c2-e063-6394a90afbe31
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY35bbb655-19e2-00c2-e063-6394a90afbe31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-744-0576282074405500 CAPSULE in 1 BOTTLE (76282-744-05) 500 capsule2024-03-01NoNoHistorical
76282-744-907628207449090 CAPSULE in 1 BOTTLE (76282-744-90) 90 capsule2025-03-14NoNoHistorical