FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
67046-721
11-digit product format
670460721
Labeler code
67046
Product ID
67046-721_7df2c5bc-87a6-30bd-e053-2a91aa0a6af0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA202433
Marketing category
ANDA
Marketing start
2017-09-20
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
2020-12-31
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
67046-721-072022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997
67046-721-142022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997
67046-721-152022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997
67046-721-202022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997
67046-721-212022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997
67046-721-282022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997
67046-721-302022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997
67046-721-602022-01-28C16284748780-1d6a99b39-eb37-a426-e053-dadaa90af4c2These 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 721 Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-721-07Tamsulosin Hydrochloride7 in 1 BLISTER PACKCAPSULE72
67046-721-14Tamsulosin Hydrochloride14 in 1 BLISTER PACKCAPSULE142
67046-721-15Tamsulosin Hydrochloride15 in 1 BLISTER PACKCAPSULE152
67046-721-20Tamsulosin Hydrochloride20 in 1 BLISTER PACKCAPSULE202
67046-721-21Tamsulosin Hydrochloride21 in 1 BLISTER PACKCAPSULE212
67046-721-28Tamsulosin Hydrochloride28 in 1 BLISTER PACKCAPSULE282
67046-721-30Tamsulosin Hydrochloride30 in 1 BLISTER PACKCAPSULE302
67046-721-60Tamsulosin Hydrochloride60 in 1 BLISTER PACKCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-721TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 8 package rows20181227_59a17ad9-3967-16b0-e053-2991aa0a9a40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN59a17ad9-3967-16b0-e053-2991aa0a9a402
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD59a17ad9-3967-16b0-e053-2991aa0a9a402
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY59a17ad9-3967-16b0-e053-2991aa0a9a402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-721-07670460721077 CAPSULE in 1 BLISTER PACK (67046-721-07) 7 capsule2017-09-200000-00-00NoNoCurrent
67046-721-146704607211414 CAPSULE in 1 BLISTER PACK (67046-721-14) 14 capsule2017-09-200000-00-00NoNoCurrent
67046-721-156704607211515 CAPSULE in 1 BLISTER PACK (67046-721-15) 15 capsule2017-09-200000-00-00NoNoCurrent
67046-721-206704607212020 CAPSULE in 1 BLISTER PACK (67046-721-20) 20 capsule2017-09-200000-00-00NoNoCurrent
67046-721-216704607212121 CAPSULE in 1 BLISTER PACK (67046-721-21) 21 capsule2017-09-200000-00-00NoNoCurrent
67046-721-286704607212828 CAPSULE in 1 BLISTER PACK (67046-721-28) 28 capsule2017-09-200000-00-00NoNoCurrent
67046-721-306704607213030 CAPSULE in 1 BLISTER PACK (67046-721-30) 30 capsule2017-09-200000-00-00NoNoCurrent
67046-721-606704607216060 CAPSULE in 1 BLISTER PACK (67046-721-60) 60 capsule2017-09-200000-00-00NoNoCurrent