FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
50090-3646
11-digit product format
500903646
Labeler code
50090
Product ID
50090-3646_0e5535f7-b97c-4e7a-96c5-58105c1c4519
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207405
Marketing category
ANDA
Marketing start
2017-08-11
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3646-02023-02-07C16284748780-1f386c649-c7e2-0266-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
50090-3646-12023-02-07C16284748780-1f386c649-c7e2-0266-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
50090-3646-02023-01-30C16284748780-1f386c649-c7e2-0266-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
50090-3646-12023-01-30C16284748780-1f386c649-c7e2-0266-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
50090-3646-0Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE308
50090-3646-1Tamsulosin Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3646-0EA - Each50090-36463c705930-2b2e-40de-8be8-dfd6983bce2512021-11-09
50090-3646-1EA - Each50090-3646078f4205-e4e9-4921-b8f2-c5150e8ffd4112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3646TAMSULOSIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20231004_3a05970e-6c34-4dff-9fd7-dde8ce60f280.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3a05970e-6c34-4dff-9fd7-dde8ce60f2808

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3646-05009036460030 CAPSULE in 1 BOTTLE (50090-3646-0) 30 capsule2018-10-100000-00-00NoNoCurrent
50090-3646-15009036460190 CAPSULE in 1 BOTTLE, PLASTIC (50090-3646-1) 90 capsule2017-08-110000-00-00NoNoCurrent