FDA.reportPublic FDA data

TAMSULOSIN HYDROCHLORIDE

Product NDC
55648-516
11-digit product format
556480516
Labeler code
55648
Product ID
55648-516_dde247ce-2fbe-4071-9af7-446d65376ec2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA078938
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
E
Listing certified through
2017-12-31
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
55648-516-012019-10-21C16284748780-1956f9ecf-ce4f-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997
55648-516-022019-10-21C16284748780-1956f9ecf-ce4f-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997
55648-516-032019-10-21C16284748780-1956f9ecf-ce4f-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997
55648-516-042019-10-21C16284748780-1956f9ecf-ce4f-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997
55648-516-052019-10-21C16284748780-1956f9ecf-ce4f-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-516-01TAMSULOSIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE301
55648-516-02TAMSULOSIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001
55648-516-03TAMSULOSIN HYDROCHLORIDE500 in 1 BOTTLECAPSULE5001
55648-516-04TAMSULOSIN HYDROCHLORIDE2 in 1 CARTONCAPSULE21
55648-516-04TAMSULOSIN HYDROCHLORIDE8 in 1 BLISTER PACKCAPSULE81
55648-516-05TAMSULOSIN HYDROCHLORIDE1 in 1 CARTONCAPSULE11
55648-516-05TAMSULOSIN HYDROCHLORIDE30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-516TAMSULOSIN HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1Legacy NDC, 7 package rows20100623_aecd6c1b-d3e3-4568-b8cb-89954f0aee5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNaecd6c1b-d3e3-4568-b8cb-89954f0aee5d1
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDaecd6c1b-d3e3-4568-b8cb-89954f0aee5d1
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYaecd6c1b-d3e3-4568-b8cb-89954f0aee5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-516-015564805160130 in 1 BOTTLEHistorical
55648-516-0255648051602100 in 1 BOTTLEHistorical
55648-516-0355648051603500 in 1 BOTTLEHistorical
55648-516-04556480516042 in 1 CARTONHistorical
55648-516-05556480516051 in 1 CARTONHistorical