FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
68071-2197
11-digit product format
680712197
Labeler code
68071
Product ID
68071-2197_c68fc96b-8d87-557a-e053-2a95a90aeffc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
2022-12-31
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
68071-2197-12023-01-30C16284748780-1ba0f9c33-0da5-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
68071-2197-32023-01-30C16284748780-1ba0f9c33-0da5-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
68071-2197-62023-01-30C16284748780-1ba0f9c33-0da5-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
68071-2197-92023-01-30C16284748780-1ba0f9c33-0da5-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
68071-2197-12021-07-07C16284748780-1ba0f9c33-0da5-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
68071-2197-32021-07-07C16284748780-1ba0f9c33-0da5-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
68071-2197-62021-07-07C16284748780-1ba0f9c33-0da5-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
68071-2197-92021-07-07C16284748780-1ba0f9c33-0da5-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
68071-2197-12021-01-29C16284748780-1ba0f9c33-0da5-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
68071-2197-32021-01-29C16284748780-1ba0f9c33-0da5-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
68071-2197-62021-01-29C16284748780-1ba0f9c33-0da5-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
68071-2197-92021-01-29C16284748780-1ba0f9c33-0da5-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
68071-2197-1Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE102
68071-2197-3Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE302
68071-2197-6Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE602
68071-2197-9Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2197TAMSULOSIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 4 package rows20210708_4fbf72e0-c7e7-0a50-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4fbf72e0-c7e7-0a50-e054-00144ff8d46c2
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4fbf72e0-c7e7-0a50-e054-00144ff8d46c2
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4fbf72e0-c7e7-0a50-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2197-16807121970110 CAPSULE in 1 BOTTLE (68071-2197-1) 10 capsule2017-05-170000-00-00NoNoCurrent
68071-2197-36807121970330 CAPSULE in 1 BOTTLE (68071-2197-3) 30 capsule2017-05-170000-00-00NoNoCurrent
68071-2197-66807121970660 CAPSULE in 1 BOTTLE (68071-2197-6) 60 capsule2017-05-170000-00-00NoNoCurrent
68071-2197-96807121970990 CAPSULE in 1 BOTTLE (68071-2197-9) 90 capsule2017-05-170000-00-00NoNoCurrent