FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
53217-154
11-digit product format
532170154
Labeler code
53217
Product ID
53217-154_c814a14d-9200-4a65-bbfb-9da05192d2e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-154-072020-01-31C16284748780-19d75b9cf-fd76-f424-e053-dadaa90a57ceThese 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
53217-154-302020-01-31C16284748780-19d75b9cf-fd76-f424-e053-dadaa90a57ceThese 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
53217-154-602020-01-31C16284748780-19d75b9cf-fd76-f424-e053-dadaa90a57ceThese 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
53217-154-902020-01-31C16284748780-19d75b9cf-fd76-f424-e053-dadaa90a57ceThese 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
53217-154-07Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE71
53217-154-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE301
53217-154-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE601
53217-154-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-154-07EA - Each53217-1542d7d8f91-c0ad-4457-90f3-9627a36dcc8d12017-03-06
53217-154-30EA - Each53217-154a0b97b37-5b50-45c8-93dc-812d4d08ed4312017-03-06
53217-154-90EA - Each53217-1547d8134f5-5c27-4359-ab4f-d7f001dee07312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-154TAMSULOSIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20170221_3d06b06c-e28f-44ea-914c-6c9393e32f58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3d06b06c-e28f-44ea-914c-6c9393e32f581
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3d06b06c-e28f-44ea-914c-6c9393e32f581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3d06b06c-e28f-44ea-914c-6c9393e32f581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-154-07532170154077 in 1 BOTTLEHistorical
53217-154-305321701543030 in 1 BOTTLEHistorical
53217-154-605321701546060 in 1 BOTTLEHistorical
53217-154-905321701549090 in 1 BOTTLEHistorical