FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
72162-2502
11-digit product format
721622502
Labeler code
72162
Product ID
72162-2502_377764cf-e917-e525-e063-6394a90a4d28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204645
Marketing category
ANDA
Marketing start
2017-01-25
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
72162-2502-0Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE1000101
72162-2502-1Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE100101
72162-2502-5Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2502-0EA - Each72162-2502ab1b1cd2-2d8b-460b-861e-98db571ff36012025-07-08
72162-2502-1EA - Each72162-2502b67caff4-1321-4753-8ec4-da182aeee85c12025-06-13
72162-2502-5EA - Each72162-250218c4a9ce-cfa0-4ff3-a7e9-863af511086112025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2502TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20250519_3533e74e-5706-f594-e063-6394a90ab8a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3533e74e-5706-f594-e063-6394a90ab8a7101
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3533e74e-5706-f594-e063-6394a90ab8a7101
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3533e74e-5706-f594-e063-6394a90ab8a7101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2502-0721622502001000 CAPSULE in 1 BOTTLE (72162-2502-0) 1000 capsule2025-05-15NoNoCurrent
72162-2502-172162250201100 CAPSULE in 1 BOTTLE (72162-2502-1) 100 capsule2025-05-15NoNoCurrent
72162-2502-572162250205500 CAPSULE in 1 BOTTLE (72162-2502-5) 500 capsule2025-05-15NoNoCurrent