FDA.reportPublic FDA data

Tamsulosin hydrochloride

Product NDC
67296-0802
11-digit product format
672960802
Labeler code
67296
Product ID
67296-0802_be375ea5-3f13-35ec-e053-2995a90a4d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA078801
Marketing category
ANDA
Marketing start
2010-04-27
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0802-12023-01-30C16284748780-1f386c649-ad61-0266-e053-dadaa90a7c1a428b176a-a1b6-2f8a-e054-00144ff8d46c
67296-0802-22023-01-30C16284748780-1f386c649-ad61-0266-e053-dadaa90a7c1a428b176a-a1b6-2f8a-e054-00144ff8d46c
67296-0802-32023-01-30C16284748780-1f386c649-ad61-0266-e053-dadaa90a7c1a428b176a-a1b6-2f8a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0802-1Tamsulosin hydrochloride7 in 1 BOTTLECAPSULE73
67296-0802-2Tamsulosin hydrochloride10 in 1 BOTTLECAPSULE103
67296-0802-3Tamsulosin hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0802TAMSULOSIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]3Legacy NDC, 3 package rows20210324_428b176a-a1b6-2f8a-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN428b176a-a1b6-2f8a-e054-00144ff8d46c3
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD428b176a-a1b6-2f8a-e054-00144ff8d46c3
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY428b176a-a1b6-2f8a-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0802-1672960802017 CAPSULE in 1 BOTTLE (67296-0802-1) 7 capsule2010-04-270000-00-00NoNoCurrent
67296-0802-26729608020210 CAPSULE in 1 BOTTLE (67296-0802-2) 10 capsule2010-04-270000-00-00NoNoCurrent
67296-0802-36729608020330 CAPSULE in 1 BOTTLE (67296-0802-3) 30 capsule2010-04-270000-00-00NoNoCurrent