FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
60723-056
11-digit product format
607230056
Labeler code
60723
Product ID
60723-056_a6a291d9-3588-0900-e053-2a95a90a34b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
Application
ANDA211885
Marketing category
ANDA
Marketing start
2019-03-11
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60723-056-102022-01-28C16284748780-1d6a99b39-c16a-a426-e053-dadaa90af4c2These 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
60723-056-502022-01-28C16284748780-1d6a99b39-c16a-a426-e053-dadaa90af4c2These 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
60723-056-10Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1001
60723-056-50Tamsulosin Hydrochloride500 in 1 PACKAGECAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60723-056TAMSULOSIN HYDROCHLORIDE CAPSULE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]1Legacy NDC, 2 package rows20200528_a6a285de-bb2c-aa42-e053-2a95a90a1ce8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa6a285de-bb2c-aa42-e053-2a95a90a1ce81
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa6a285de-bb2c-aa42-e053-2a95a90a1ce81
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa6a285de-bb2c-aa42-e053-2a95a90a1ce81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60723-056-1060723005610100 CAPSULE in 1 BOTTLE (60723-056-10) 100 capsule2019-03-110000-00-00NoNoCurrent
60723-056-5060723005650500 CAPSULE in 1 PACKAGE (60723-056-50) 500 capsule2019-03-110000-00-00NoNoCurrent