FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
50436-0598
11-digit product format
504360598
Labeler code
50436
Product ID
50436-0598_aa2aac23-2d3c-408d-8409-81ce64a0c695
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
Marketing end
0000-00-00
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0598-12021-01-29C16284748780-1ba0f9c33-2f37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
50436-0598-32021-01-29C16284748780-1ba0f9c33-2f37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0598-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE302
50436-0598-3Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0598TAMSULOSIN HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20190222_f0ac7598-8e98-47e3-a9f7-ee393d807ca2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf0ac7598-8e98-47e3-a9f7-ee393d807ca22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0598-15043605980130 in 1 BOTTLEHistorical
50436-0598-35043605980390 in 1 BOTTLEHistorical