FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71335-0711
11-digit product format
713350711
Labeler code
71335
Product ID
71335-0711_48f57acf-24de-4415-8c42-f8c326091704
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0711-12024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-22024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-32024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-42024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-52024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-62024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-72024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-82024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-92024-01-30C16284748780-11030e365-0ebb-111a-e063-dadaa90a10e2These 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
71335-0711-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
71335-0711-2Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1004
71335-0711-3Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE604
71335-0711-4Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE104
71335-0711-5Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904
71335-0711-6Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE1804
71335-0711-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE74
71335-0711-8Tamsulosin Hydrochloride15 in 1 BOTTLECAPSULE154
71335-0711-9Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0711-5EA - Each71335-071139ee1573-b4a9-4e49-b75b-33a284fdb61512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0711TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4Legacy NDC, 9 package rows20220201_48f57acf-24de-4415-8c42-f8c326091704.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN48f57acf-24de-4415-8c42-f8c3260917044
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD48f57acf-24de-4415-8c42-f8c3260917044
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY48f57acf-24de-4415-8c42-f8c3260917044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0711-17133507110130 CAPSULE in 1 BOTTLE (71335-0711-1) 30 capsule2022-01-270000-00-00NoNoCurrent
71335-0711-271335071102100 CAPSULE in 1 BOTTLE (71335-0711-2) 100 capsule2022-01-270000-00-00NoNoCurrent
71335-0711-37133507110360 CAPSULE in 1 BOTTLE (71335-0711-3) 60 capsule2022-01-270000-00-00NoNoCurrent
71335-0711-47133507110410 CAPSULE in 1 BOTTLE (71335-0711-4) 10 capsule2022-01-270000-00-00NoNoCurrent
71335-0711-57133507110590 CAPSULE in 1 BOTTLE (71335-0711-5) 90 capsule2018-02-280000-00-00NoNoCurrent
71335-0711-671335071106180 CAPSULE in 1 BOTTLE (71335-0711-6) 180 capsule2022-01-270000-00-00NoNoCurrent
71335-0711-7713350711077 CAPSULE in 1 BOTTLE (71335-0711-7) 7 capsule2022-01-270000-00-00NoNoCurrent
71335-0711-87133507110815 CAPSULE in 1 BOTTLE (71335-0711-8) 15 capsule2022-01-270000-00-00NoNoCurrent
71335-0711-971335071109120 CAPSULE in 1 BOTTLE (71335-0711-9) 120 capsule2022-01-270000-00-00NoNoCurrent