FDA.reportPublic FDA data

FLOMAX

Product NDC
0024-5837
11-digit product format
000245837
Labeler code
0024
Product ID
0024-5837_f17b7d67-baa2-9958-e053-2a95a90a0662
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
sanofi-aventis U.S. LLC
Application
NDA020579
Marketing category
NDA
Marketing start
2019-04-16
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
2024-12-31
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
0024-5837-012024-01-30C16284748780-11030e365-4b46-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLOMAX safely and effectively. See full prescribing information for FLOMAX. FLOMAX ® (tamsulosin hydrochloride, USP) capsules, for oral use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5837-01EA - Each0024-5837393fdc77-6677-45f2-9bf5-7dadd15082f312019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5837FLOMAX (TAMSULOSIN HYDROCHLORIDE) CAPSULE [SANOFI-AVENTIS U.S. LLC]10Legacy NDC20250104_6771ad8e-ac92-4aec-b484-5d8350a353f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863671Flomax 0.4 MG Oral CapsulePSNb3384748-92f1-0b49-e053-2a95a90abc736
863669tamsulosin HCl 0.4 MG Oral CapsulePSNb3384748-92f1-0b49-e053-2a95a90abc736
863671tamsulosin hydrochloride 0.4 MG Oral Capsule [Flomax]SBDb3384748-92f1-0b49-e053-2a95a90abc736
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDb3384748-92f1-0b49-e053-2a95a90abc736
863671Flomax 0.4 MG Oral CapsuleSYb3384748-92f1-0b49-e053-2a95a90abc736
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYb3384748-92f1-0b49-e053-2a95a90abc736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5837-0100024583701100 CAPSULE in 1 BOTTLE (0024-5837-01) 100 capsule2019-04-160000-00-00NoNoCurrent