FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
50090-4906
11-digit product format
500904906
Labeler code
50090
Product ID
50090-4906_0ec71c7e-f1e8-47a8-bdc2-e9ccefccf6f2
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
50090-4906-02023-02-07C16284748780-1f386c649-d299-0266-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
50090-4906-02023-01-30C16284748780-1f386c649-d299-0266-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
50090-4906-0Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4906-0EA - Each50090-49061c2d8131-d55e-46a8-8298-8d66bb53f60812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4906TAMSULOSIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230922_74a8ef78-908f-4671-91a3-ec3a044aabf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY74a8ef78-908f-4671-91a3-ec3a044aabf24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4906-05009049060090 CAPSULE in 1 BOTTLE (50090-4906-0) 90 capsule2020-02-170000-00-00NoNoCurrent