FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
68071-1934
11-digit product format
680711934
Labeler code
68071
Product ID
68071-1934_ed24e789-ff48-0be6-e053-2995a90a4135
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA090931
Marketing category
ANDA
Marketing start
2010-07-15
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
2023-12-31
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
68071-1934-12025-01-30C16284748780-12cef2736-b465-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-1934-32025-01-30C16284748780-12cef2736-b465-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-1934-62025-01-30C16284748780-12cef2736-b465-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
68071-1934-92025-01-30C16284748780-12cef2736-b465-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE 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
68071-1934-1Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE104
68071-1934-3Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
68071-1934-6Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE604
68071-1934-9Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1934TAMSULOSIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS, INC.]4Legacy NDC, 4 package rows20221111_49245aec-9a0f-459e-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN49245aec-9a0f-459e-e054-00144ff8d46c4
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD49245aec-9a0f-459e-e054-00144ff8d46c4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY49245aec-9a0f-459e-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1934-16807119340110 CAPSULE in 1 BOTTLE (68071-1934-1) 10 capsule2017-02-220000-00-00NoNoCurrent
68071-1934-36807119340330 CAPSULE in 1 BOTTLE (68071-1934-3) 30 capsule2017-02-220000-00-00NoNoCurrent
68071-1934-66807119340660 CAPSULE in 1 BOTTLE (68071-1934-6) 60 capsule2017-02-220000-00-00NoNoCurrent
68071-1934-96807119340990 CAPSULE in 1 BOTTLE (68071-1934-9) 90 capsule2017-02-220000-00-00NoNoCurrent