FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
58118-0598
11-digit product format
581180598
Labeler code
58118
Product ID
58118-0598_b0269c97-f391-4da4-e053-2a95a90a0b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA202433
Marketing category
ANDA
Marketing start
2019-11-19
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0598-82024-01-30C16284748780-11030e365-2d46-111a-e063-dadaa90a10e2These 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
58118-0598-8Tamsulosin Hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0598TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]2Legacy NDC, 1 package rows20200926_14c1fc86-76bd-499d-871a-e6830bea2322.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY14c1fc86-76bd-499d-871a-e6830bea23222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0598-85811805980830 CAPSULE in 1 BLISTER PACK (58118-0598-8) 30 capsule2019-11-190000-00-00NoNoCurrent