FDA.reportPublic FDA data

Tamsulosin hydrochloride

Product NDC
43353-663
11-digit product format
433530663
Labeler code
43353
Product ID
43353-663_f6a44bf9-c610-4be8-a289-2bbbe103b9c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078801
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
No
Listing certified through
2019-12-31
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
43353-663-302020-01-31C16284748780-19d75b9d0-d375-f424-e053-dadaa90a57ceTamsulosin hydrochloride capsules USP, 0.4 mg These highlights do not include all the information needed to use Tamsulosin hydrochloride safely and effectively. See full prescribing information for Tamsulosin hydrochloride. Tamsulosin hydrochloride (Tamsulosin hydrochloride) CAPSULE for ORAL use. Initial U.S. Approval: 1997
43353-663-532020-01-31C16284748780-19d75b9d0-d375-f424-e053-dadaa90a57ceTamsulosin hydrochloride capsules USP, 0.4 mg These highlights do not include all the information needed to use Tamsulosin hydrochloride safely and effectively. See full prescribing information for Tamsulosin hydrochloride. Tamsulosin hydrochloride (Tamsulosin hydrochloride) CAPSULE for ORAL use. Initial U.S. Approval: 1997
43353-663-602020-01-31C16284748780-19d75b9d0-d375-f424-e053-dadaa90a57ceTamsulosin hydrochloride capsules USP, 0.4 mg These highlights do not include all the information needed to use Tamsulosin hydrochloride safely and effectively. See full prescribing information for Tamsulosin hydrochloride. Tamsulosin hydrochloride (Tamsulosin hydrochloride) CAPSULE for ORAL use. Initial U.S. Approval: 1997
43353-663-802020-01-31C16284748780-19d75b9d0-d375-f424-e053-dadaa90a57ceTamsulosin hydrochloride capsules USP, 0.4 mg These highlights do not include all the information needed to use Tamsulosin hydrochloride safely and effectively. See full prescribing information for Tamsulosin hydrochloride. Tamsulosin hydrochloride (Tamsulosin hydrochloride) CAPSULE for ORAL use. Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-663-30Tamsulosin hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
43353-663-53Tamsulosin hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601
43353-663-60Tamsulosin hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901
43353-663-80Tamsulosin hydrochloride180 in 1 BOTTLE, PLASTICCAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-663-30EA - Each43353-663433f7441-0300-4b1a-a4af-3c61cfd2f4c112014-06-03
43353-663-53EA - Each43353-6636b7582ca-1c3a-4eab-899b-28ed4e154a9812014-06-03
43353-663-60EA - Each43353-6639482eb9c-9798-4c3b-ad52-e3646460da2f12014-06-03
43353-663-80EA - Each43353-663e3c61745-0a99-4f45-a258-3a61ee8ed4c012014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-663TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20140503_d48bffcf-1070-46b0-a5f8-8ea1aa53ba27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNd48bffcf-1070-46b0-a5f8-8ea1aa53ba271
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDd48bffcf-1070-46b0-a5f8-8ea1aa53ba271
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYd48bffcf-1070-46b0-a5f8-8ea1aa53ba271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-663-304335306633030 in 1 BOTTLE, PLASTICHistorical
43353-663-534335306635360 in 1 BOTTLE, PLASTICHistorical
43353-663-604335306636090 in 1 BOTTLE, PLASTICHistorical
43353-663-8043353066380180 in 1 BOTTLE, PLASTICHistorical