FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71335-0398
11-digit product format
713350398
Labeler code
71335
Product ID
71335-0398_812a5db0-ce5b-47df-a7f9-ca14cdb1532b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
.4 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii11SV1951MR
Rxcui863669

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
71335-0398-12024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-22024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-32024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-42024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-52024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-62024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-72024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-82024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-92024-05-17C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-12024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-22024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-32024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-42024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-52024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-62024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-72024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-82024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-92024-01-30C16284748780-11030e365-694d-111a-e063-dadaa90a10e2These 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
71335-0398-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE308
71335-0398-2Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1008
71335-0398-3Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE608
71335-0398-4Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE108
71335-0398-5Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE908
71335-0398-6Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE1808
71335-0398-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE78
71335-0398-8Tamsulosin Hydrochloride15 in 1 BOTTLECAPSULE158
71335-0398-9Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0398-1EA - Each71335-0398dfb0507b-8505-47f8-b98d-76ad4cb66fd112018-03-08
71335-0398-2EA - Each71335-03986c2d24a1-a94c-49c5-bf59-8ea02434d21e12018-03-08
71335-0398-3EA - Each71335-03980ab15164-e5eb-4e7c-954a-a0b987ca121812018-03-08
71335-0398-4EA - Each71335-0398bcc86961-ed9a-46e4-864e-2d293cf555e712018-03-08
71335-0398-5EA - Each71335-039897a37b92-0067-418b-98af-99722ce87eff12018-03-08
71335-0398-6EA - Each71335-039876031e98-8887-4348-92af-3bd1d993646712018-03-08
71335-0398-7EA - Each71335-03981eb019e2-2d97-4981-95dc-6860c6330b5a12018-03-08
71335-0398-8EA - Each71335-0398fd3ac929-d466-47dd-9f73-41f0cdfa590b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0398TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 9 package rows20240518_58bdac81-680a-4fd2-8f05-dd5b86553569.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY58bdac81-680a-4fd2-8f05-dd5b865535698

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0398-17133503980130 CAPSULE in 1 BOTTLE (71335-0398-1) 30 capsule2018-04-250000-00-00NoNoCurrent
71335-0398-271335039802100 CAPSULE in 1 BOTTLE (71335-0398-2) 100 capsule2019-01-110000-00-00NoNoCurrent
71335-0398-37133503980360 CAPSULE in 1 BOTTLE (71335-0398-3) 60 capsule2018-04-130000-00-00NoNoCurrent
71335-0398-47133503980410 CAPSULE in 1 BOTTLE (71335-0398-4) 10 capsule2018-11-080000-00-00NoNoCurrent
71335-0398-57133503980590 CAPSULE in 1 BOTTLE (71335-0398-5) 90 capsule2018-04-130000-00-00NoNoCurrent
71335-0398-671335039806180 CAPSULE in 1 BOTTLE (71335-0398-6) 180 capsule2024-04-050000-00-00NoNoCurrent
71335-0398-7713350398077 CAPSULE in 1 BOTTLE (71335-0398-7) 7 capsule2018-12-100000-00-00NoNoCurrent
71335-0398-87133503980815 CAPSULE in 1 BOTTLE (71335-0398-8) 15 capsule2018-06-110000-00-00NoNoCurrent
71335-0398-971335039809120 CAPSULE in 1 BOTTLE (71335-0398-9) 120 capsule2019-07-220000-00-00NoNoCurrent