FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
50090-5553
11-digit product format
500905553
Labeler code
50090
Product ID
50090-5553_d0a256d0-0bfc-45b1-84b4-1335cf5c1550
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
.4 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii11SV1951MR
Rxcui863669

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5553-02023-02-07C16284748780-1f386c649-a428-0266-e053-dadaa90a7c1aThese 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 Initial U.S. Approval: 1997
50090-5553-02023-01-30C16284748780-1f386c649-a428-0266-e053-dadaa90a7c1aThese 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 Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5553-0Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5553TAMSULOSIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20230208_1d70b04e-ca08-48d3-937b-eb701b40dd8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1d70b04e-ca08-48d3-937b-eb701b40dd8a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5553-05009055530090 CAPSULE in 1 BOTTLE (50090-5553-0) 90 capsule2021-06-110000-00-00NoNoCurrent