FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
72603-115
11-digit product format
726030115
Labeler code
72603
Product ID
72603-115_d26ad47b-f3ef-45d6-b39d-f64929a54489
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-115-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1002
72603-115-02Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-115-01EA - Each72603-11509595324-860d-4ffc-ba70-09093db4c30412023-03-13
72603-115-02EA - Each72603-115e6a300b4-ce6c-4360-987c-abc92b16241412023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-115TAMSULOSIN HYDROCHLORIDE CAPSULE [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 2 package rows20231130_7ab14f88-414a-448f-b7bf-de8c9e1b1eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN00bb2d71-1f21-494c-aa66-a82be3a0a8e63
863669tamsulosin HCl 0.4 MG Oral CapsulePSN6a2a4cc7-c88a-4555-a247-d1e63206ffc53
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD00bb2d71-1f21-494c-aa66-a82be3a0a8e63
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD6a2a4cc7-c88a-4555-a247-d1e63206ffc53
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY00bb2d71-1f21-494c-aa66-a82be3a0a8e63
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY6a2a4cc7-c88a-4555-a247-d1e63206ffc53
863669tamsulosin HCl 0.4 MG Oral CapsulePSN0106b6ca-6c86-3914-e063-6394a90ab69f2
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7ab14f88-414a-448f-b7bf-de8c9e1b1eb32
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD0106b6ca-6c86-3914-e063-6394a90ab69f2
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7ab14f88-414a-448f-b7bf-de8c9e1b1eb32
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7ab14f88-414a-448f-b7bf-de8c9e1b1eb32
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY0106b6ca-6c86-3914-e063-6394a90ab69f2
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4d481f6b-0232-d4af-e063-6394a90ad1af1
863669tamsulosin HCl 0.4 MG Oral CapsulePSN199a74b0-47bf-012d-e063-6394a90ac3751
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4d481f6b-0232-d4af-e063-6394a90ad1af1
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD199a74b0-47bf-012d-e063-6394a90ac3751
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4d481f6b-0232-d4af-e063-6394a90ad1af1
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY199a74b0-47bf-012d-e063-6394a90ac3751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72603-115-0172603011501100 CAPSULE in 1 BOTTLE (72603-115-01) 100 capsule2013-04-300000-00-00NoNoCurrent
72603-115-0272603011502500 CAPSULE in 1 BOTTLE (72603-115-02) 500 capsule2013-04-300000-00-00NoNoCurrent