FDA.reportPublic FDA data

TAMSULOSIN HYDROCHLORIDE

Product NDC
52959-034
11-digit product format
529590034
Labeler code
52959
Product ID
52959-034_1d7bd683-a263-467b-ac59-22f200b04aef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA078938
Marketing category
ANDA
Marketing start
2010-04-27
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
E
Listing certified through
2017-12-31
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
52959-034-302019-11-13C16284748780-197449f38-cc26-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997
52959-034-602019-11-13C16284748780-197449f38-cc26-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-034-30TAMSULOSIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE303
52959-034-60TAMSULOSIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE603

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]3
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-034TAMSULOSIN HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 2 package rows20120120_af558603-15f3-43e4-9ee5-9d38d59ef1c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNaf558603-15f3-43e4-9ee5-9d38d59ef1c13
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDaf558603-15f3-43e4-9ee5-9d38d59ef1c13
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYaf558603-15f3-43e4-9ee5-9d38d59ef1c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-034-305295900343030 in 1 BOTTLEHistorical
52959-034-605295900346060 in 1 BOTTLEHistorical