FDA.reportPublic FDA data

TAMSULOSIN HYDROCHLORIDE

Product NDC
33261-839
11-digit product format
332610839
Labeler code
33261
Product ID
33261-839_22df39d3-1e71-4b07-8d0e-9ed581d66142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
No
Listing certified through
2019-12-31
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
33261-839-302020-01-31C16284748780-19d75b9d1-2538-f424-e053-dadaa90a57ceThese 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
33261-839-902020-01-31C16284748780-19d75b9d1-2538-f424-e053-dadaa90a57ceThese 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
33261-839-30TAMSULOSIN HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE301
33261-839-90TAMSULOSIN HYDROCHLORIDE90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-839-30EA - Each33261-83967c42bd8-697b-4d42-b45c-ccd0f54ad77012015-10-02
33261-839-90EA - Each33261-83987ca11a9-737c-4084-afa7-fdea7564051812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-839TAMSULOSIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140213_a82c4269-b53d-4e7f-877a-88f005826678.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa82c4269-b53d-4e7f-877a-88f0058266781
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa82c4269-b53d-4e7f-877a-88f0058266781
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa82c4269-b53d-4e7f-877a-88f0058266781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-839-303326108393030 in 1 BOTTLE, PLASTICHistorical
33261-839-903326108399090 in 1 BOTTLE, PLASTICHistorical