FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
67296-1646
11-digit product format
672961646
Labeler code
67296
Product ID
67296-1646_b8df8cb5-10a0-58db-e053-2a95a90a8313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug. Inc.
Application
ANDA207405
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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
67296-1646-12026-01-29C16284748780-1f386c649-9d37-0266-e053-dadaa90a7c1aTamsulosin 0.4mg
67296-1646-72026-01-29C16284748780-1f386c649-9d37-0266-e053-dadaa90a7c1aTamsulosin 0.4mg
67296-1646-12024-08-09C16284748780-1f386c649-9d37-0266-e053-dadaa90a7c1aTamsulosin 0.4mg
67296-1646-72024-08-09C16284748780-1f386c649-9d37-0266-e053-dadaa90a7c1aTamsulosin 0.4mg
67296-1646-12023-01-30C16284748780-1f386c649-9d37-0266-e053-dadaa90a7c1aTamsulosin 0.4mg
67296-1646-72023-01-30C16284748780-1f386c649-9d37-0266-e053-dadaa90a7c1aTamsulosin 0.4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1646-1Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE108
67296-1646-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE78
67296-1646-3Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1646TAMSULOSIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG. INC.]8Legacy NDC, 2 package rows20240810_8902ff1a-8acb-465b-e053-2995a90a1ce4.zip
67296-1646TAMSULOSIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG. INC.]1Legacy NDC, 1 package rows20240810_f4c298d5-affb-7b56-e053-2a95a90a3d55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf4c298d5-affb-7b56-e053-2a95a90a3d551
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf4c298d5-affb-7b56-e053-2a95a90a3d551
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf4c298d5-affb-7b56-e053-2a95a90a3d551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1646-16729616460110 CAPSULE in 1 BOTTLE (67296-1646-1) 10 capsule2019-01-010000-00-00NoNoCurrent
67296-1646-36729616460330 in 1 BOTTLEHistorical
67296-1646-7672961646077 CAPSULE in 1 BOTTLE (67296-1646-7) 7 capsule2019-01-010000-00-00NoNoCurrent