FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
50090-6699
11-digit product format
500906699
Labeler code
50090
Product ID
50090-6699_6cdc389c-e81f-40db-bf0c-165425e3525a
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6699-0Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE303
50090-6699-1Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6699-0EA - Each50090-6699ea0bcef9-5886-4fbb-9aa7-4ef44c98a5ed12023-10-16
50090-6699-1EA - Each50090-6699a56b8b27-0d9b-461d-8027-8fab2362e5c712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6699TAMSULOSIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230928_6a2a4cc7-c88a-4555-a247-d1e63206ffc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN6a2a4cc7-c88a-4555-a247-d1e63206ffc53
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD6a2a4cc7-c88a-4555-a247-d1e63206ffc53
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY6a2a4cc7-c88a-4555-a247-d1e63206ffc53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6699-05009066990030 CAPSULE in 1 BOTTLE (50090-6699-0) 30 capsule2023-09-22NoNoHistorical
50090-6699-15009066990190 CAPSULE in 1 BOTTLE (50090-6699-1) 90 capsule2023-09-22NoNoHistorical